Application Information

This drug has been submitted to the FDA under the reference 010347/002.

Names and composition

"DELALUTIN" is the commercial name of a drug composed of HYDROXYPROGESTERONE CAPROATE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
010347/002 DELALUTIN HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 250MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
010347/004 DELALUTIN HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 125MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
016911/001 DELALUTIN HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 125MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
016911/002 DELALUTIN HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 250MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
010347/002 DELALUTIN HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 250MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
010347/004 DELALUTIN HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 125MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
016911/001 DELALUTIN HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 125MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
016911/002 DELALUTIN HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 250MG per ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
017439/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 125MG per ML
017439/002 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 250MG per ML
018004/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 125MG per ML
021945/001 MAKENA HYDROXYPROGESTERONE CAPROATE SOLUTION/INTRAMUSCULAR 1250MG per 5ML (250MG per ML)
021945/002 MAKENA PRESERVATIVE FREE HYDROXYPROGESTERONE CAPROATE SOLUTION/INTRAMUSCULAR 250MG per ML (250MG per ML)
021945/003 MAKENA PRESERVATIVE FREE HYDROXYPROGESTERONE CAPROATE SOLUTION/INTRAMUSCULAR 250MG per ML (250MG per ML)
089330/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE Injectable/ Injection 125MG per ML
089331/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE Injectable/ Injection 250MG per ML
200271/001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE INJECTABLE/INJECTION 250MG per ML

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Answered questions

Delalutin injections during pregnancy?
My doctor and I are discussing whether or not I should get weekly shots of delalutin to decrease my risk of preterm labor during my pregnancy. I am 20 weeks along....I had preterm labor at 28 weeks with my 1st pregnancy and at 30 weeks with my 2nd...with bedrest and oral medication I did carry both babies to full... Asked by Kasi Nettleingham 1 year ago.

My doctor and I are discussing whether or not I should get weekly shots of delalutin to decrease my risk of preterm labor during my pregnancy. I am 20 weeks along....I had preterm labor at 28 weeks with my 1st pregnancy and at 30 weeks with my 2nd...with bedrest and oral medication I did carry both babies to full term. Does anyone have any information on delalutin? Answered by Francie Gardon 1 year ago.

I do not have any info on the drug, but I do believe that you carried to full term and yes it was probably a pain in the butt, but I think that you should be fine carrying full term again. If you think about injecting yourself with this drug then think about the baby and what the chemicals in the drug can do to your unborn baby. I take it your other two were healthy babies and then why take the chance of harming the third? I personally want my children to be as healthy and vibrant as possible. Do you know the long term effects of the drug on your child when it becomes an adult? If not then it would not be worth it at all to me. I am not trying to be mean at all, I am just trying to give you a little advise. Answered by Lorelei Gibert 1 year ago.

I'm 29 weeks pregnant and have had my blood taken about 5 times so far during pregnancy and have had 2 or 3 injections. It's not over yet though!! I used to feel the same way about needles but have started to get braver. I had a miscarriage a few months before this pregnancy and had some blood tests, injections, and IVs at the hospital during that whole ordeal. Before that miscarriage I only had to deal with needles once every few years, lol. Now I'm slowly getting used to them. I guess when you're gonna be a mom it's a small price to pay, and we need to be tough for our children! I'm a wimp about pain but I'd die for my baby and I haven't even met him yet. Answered by Johnathan Feldtman 1 year ago.

My mother had this injection to carry me to term 35 years ago. The doctor and my parents were primarily concerned with be being a healthy, full-term baby and did not know, or were willing to risk the side effects the drug had on my brain. I have a congenital deformity in both feet, scoliosis, schizoaffective disorder, severe ADHD, and nerve issues (in my body, not brain). It has been linked to aggressiveness in children which, in my case, is due to the fact that I require a MUCH more extreme stimulus to feel emotions, be it happy, sad, pleasure, pain (both physical and emotional), satisfaction, etc. Because of this, interpersonal relationships are extremely difficult for me; I have even been diagnosed as a psychopath due to the fact that I only feel empathy, sympathy, guilt, or pleasure from extreme situations. (Psychopaths are considered to have no emotions; they feel no guilt, remorse, or empathy towards others; they only feel pleasure from extreme, usually inappropriate, situations involving a major adrenaline or endorphin release; they take pleasure in indiscriminately causing pain and harm. It is this last trait that I do not share or understand and changed my diagnosis.) Bottom line, seriously consider the life you are bringing into the world and whether you are willing to care for a special needs son or daughter from birth. My parents wanted a "trophy" child, not one that would require any actual work. This certainly worked against me as well, but the delalutin shaped my brain (and feet and spine) a bit wrong from the start. As a result I have had one lower leg amputation, attempted suicide at the age of 8, and will most likely be on disability for the rest of my life. Don't use that drug unless you are ready for a lifetime commitment to ensuring your child's emotional and physical health. Answered by Louvenia Ahumada 1 year ago.


What do you think of Delalutin shots given weekly for help with trying to decrease the chance of preterm birth?
I was reading up on delalutin and read that it can cause still birth and birth defects. My doctor said its optional to get the shots. Also she said that there is a 15-30% chance that it will help. Im wondering your thoughts on this. Do you think it is worth the chances that can occur? I am 20 weeks, and did go... Asked by Edmond Merrih 1 year ago.

I was reading up on delalutin and read that it can cause still birth and birth defects. My doctor said its optional to get the shots. Also she said that there is a 15-30% chance that it will help. Im wondering your thoughts on this. Do you think it is worth the chances that can occur? I am 20 weeks, and did go into premature labor with my daughter (3 months). Its an important decision but I'm confused in what would be the best choice. Have you gotten these shots?? What is your outlook?? Thanks in advance. Answered by Grisel Whitacre 1 year ago.

i have never heard of it but it sounds like the risks may outweigh the benfits. I would look up with percentage of babies have birthdefects or dive vs. the15-30% chance it will work. If the percentage of ill effects to the baby are less than 3% i would do it.... Answered by Julieann Barquera 1 year ago.


Delalutin injections during pregnancy?
My doctor and I are discussing whether or not I should get weekly shots of delalutin to decrease my risk of preterm labor during my pregnancy. I am 20 weeks along....I had preterm labor at 28 weeks with my 1st pregnancy and at 30 weeks with my 2nd...with bedrest and oral medication I did carry both babies to full... Asked by Sherlyn Barhorst 1 year ago.

My doctor and I are discussing whether or not I should get weekly shots of delalutin to decrease my risk of preterm labor during my pregnancy. I am 20 weeks along....I had preterm labor at 28 weeks with my 1st pregnancy and at 30 weeks with my 2nd...with bedrest and oral medication I did carry both babies to full term. Does anyone have any information on delalutin? Answered by Lisa Cater 1 year ago.

I do not have any info on the drug, but I do believe that you carried to full term and yes it was probably a pain in the butt, but I think that you should be fine carrying full term again. If you think about injecting yourself with this drug then think about the baby and what the chemicals in the drug can do to your unborn baby. I take it your other two were healthy babies and then why take the chance of harming the third? I personally want my children to be as healthy and vibrant as possible. Do you know the long term effects of the drug on your child when it becomes an adult? If not then it would not be worth it at all to me. I am not trying to be mean at all, I am just trying to give you a little advise. Answered by Glynis Obin 1 year ago.

I'm 29 weeks pregnant and have had my blood taken about 5 times so far during pregnancy and have had 2 or 3 injections. It's not over yet though!! I used to feel the same way about needles but have started to get braver. I had a miscarriage a few months before this pregnancy and had some blood tests, injections, and IVs at the hospital during that whole ordeal. Before that miscarriage I only had to deal with needles once every few years, lol. Now I'm slowly getting used to them. I guess when you're gonna be a mom it's a small price to pay, and we need to be tough for our children! I'm a wimp about pain but I'd die for my baby and I haven't even met him yet. Answered by Ayanna Mcritchie 1 year ago.

My mother had this injection to carry me to term 35 years ago. The doctor and my parents were primarily concerned with be being a healthy, full-term baby and did not know, or were willing to risk the side effects the drug had on my brain. I have a congenital deformity in both feet, scoliosis, schizoaffective disorder, severe ADHD, and nerve issues (in my body, not brain). It has been linked to aggressiveness in children which, in my case, is due to the fact that I require a MUCH more extreme stimulus to feel emotions, be it happy, sad, pleasure, pain (both physical and emotional), satisfaction, etc. Because of this, interpersonal relationships are extremely difficult for me; I have even been diagnosed as a psychopath due to the fact that I only feel empathy, sympathy, guilt, or pleasure from extreme situations. (Psychopaths are considered to have no emotions; they feel no guilt, remorse, or empathy towards others; they only feel pleasure from extreme, usually inappropriate, situations involving a major adrenaline or endorphin release; they take pleasure in indiscriminately causing pain and harm. It is this last trait that I do not share or understand and changed my diagnosis.) Bottom line, seriously consider the life you are bringing into the world and whether you are willing to care for a special needs son or daughter from birth. My parents wanted a "trophy" child, not one that would require any actual work. This certainly worked against me as well, but the delalutin shaped my brain (and feet and spine) a bit wrong from the start. As a result I have had one lower leg amputation, attempted suicide at the age of 8, and will most likely be on disability for the rest of my life. Don't use that drug unless you are ready for a lifetime commitment to ensuring your child's emotional and physical health. Answered by Joshua Stallsworth 1 year ago.


What do you think of Delalutin shots given weekly for help with trying to decrease the chance of preterm birth?
I was reading up on delalutin and read that it can cause still birth and birth defects. My doctor said its optional to get the shots. Also she said that there is a 15-30% chance that it will help. Im wondering your thoughts on this. Do you think it is worth the chances that can occur? I am 20 weeks, and did go... Asked by Mae Perreault 1 year ago.

I was reading up on delalutin and read that it can cause still birth and birth defects. My doctor said its optional to get the shots. Also she said that there is a 15-30% chance that it will help. Im wondering your thoughts on this. Do you think it is worth the chances that can occur? I am 20 weeks, and did go into premature labor with my daughter (3 months). Its an important decision but I'm confused in what would be the best choice. Have you gotten these shots?? What is your outlook?? Thanks in advance. Answered by Colin Beniquez 1 year ago.

i have never heard of it but it sounds like the risks may outweigh the benfits. I would look up with percentage of babies have birthdefects or dive vs. the15-30% chance it will work. If the percentage of ill effects to the baby are less than 3% i would do it.... Answered by Jenine Ferster 1 year ago.


Delalutin injections during pregnancy?
My doctor and I are discussing whether or not I should get weekly shots of delalutin to decrease my risk of preterm labor during my pregnancy. I am 20 weeks along....I had preterm labor at 28 weeks with my 1st pregnancy and at 30 weeks with my 2nd...with bedrest and oral medication I did carry both babies to full... Asked by Cleopatra Attia 1 year ago.

My doctor and I are discussing whether or not I should get weekly shots of delalutin to decrease my risk of preterm labor during my pregnancy. I am 20 weeks along....I had preterm labor at 28 weeks with my 1st pregnancy and at 30 weeks with my 2nd...with bedrest and oral medication I did carry both babies to full term. Does anyone have any information on delalutin? Answered by Nathanael Litano 1 year ago.

I do not have any info on the drug, but I do believe that you carried to full term and yes it was probably a pain in the butt, but I think that you should be fine carrying full term again. If you think about injecting yourself with this drug then think about the baby and what the chemicals in the drug can do to your unborn baby. I take it your other two were healthy babies and then why take the chance of harming the third? I personally want my children to be as healthy and vibrant as possible. Do you know the long term effects of the drug on your child when it becomes an adult? If not then it would not be worth it at all to me. I am not trying to be mean at all, I am just trying to give you a little advise. Answered by Gene Guerino 1 year ago.

I'm 29 weeks pregnant and have had my blood taken about 5 times so far during pregnancy and have had 2 or 3 injections. It's not over yet though!! I used to feel the same way about needles but have started to get braver. I had a miscarriage a few months before this pregnancy and had some blood tests, injections, and IVs at the hospital during that whole ordeal. Before that miscarriage I only had to deal with needles once every few years, lol. Now I'm slowly getting used to them. I guess when you're gonna be a mom it's a small price to pay, and we need to be tough for our children! I'm a wimp about pain but I'd die for my baby and I haven't even met him yet. Answered by Veta Heerdt 1 year ago.

My mother had this injection to carry me to term 35 years ago. The doctor and my parents were primarily concerned with be being a healthy, full-term baby and did not know, or were willing to risk the side effects the drug had on my brain. I have a congenital deformity in both feet, scoliosis, schizoaffective disorder, severe ADHD, and nerve issues (in my body, not brain). It has been linked to aggressiveness in children which, in my case, is due to the fact that I require a MUCH more extreme stimulus to feel emotions, be it happy, sad, pleasure, pain (both physical and emotional), satisfaction, etc. Because of this, interpersonal relationships are extremely difficult for me; I have even been diagnosed as a psychopath due to the fact that I only feel empathy, sympathy, guilt, or pleasure from extreme situations. (Psychopaths are considered to have no emotions; they feel no guilt, remorse, or empathy towards others; they only feel pleasure from extreme, usually inappropriate, situations involving a major adrenaline or endorphin release; they take pleasure in indiscriminately causing pain and harm. It is this last trait that I do not share or understand and changed my diagnosis.) Bottom line, seriously consider the life you are bringing into the world and whether you are willing to care for a special needs son or daughter from birth. My parents wanted a "trophy" child, not one that would require any actual work. This certainly worked against me as well, but the delalutin shaped my brain (and feet and spine) a bit wrong from the start. As a result I have had one lower leg amputation, attempted suicide at the age of 8, and will most likely be on disability for the rest of my life. Don't use that drug unless you are ready for a lifetime commitment to ensuring your child's emotional and physical health. Answered by Gertie Mcgrady 1 year ago.


What do you think of Delalutin shots given weekly for help with trying to decrease the chance of preterm birth?
I was reading up on delalutin and read that it can cause still birth and birth defects. My doctor said its optional to get the shots. Also she said that there is a 15-30% chance that it will help. Im wondering your thoughts on this. Do you think it is worth the chances that can occur? I am 20 weeks, and did go... Asked by Taunya Zazula 1 year ago.

I was reading up on delalutin and read that it can cause still birth and birth defects. My doctor said its optional to get the shots. Also she said that there is a 15-30% chance that it will help. Im wondering your thoughts on this. Do you think it is worth the chances that can occur? I am 20 weeks, and did go into premature labor with my daughter (3 months). Its an important decision but I'm confused in what would be the best choice. Have you gotten these shots?? What is your outlook?? Thanks in advance. Answered by Frank Siad 1 year ago.

i have never heard of it but it sounds like the risks may outweigh the benfits. I would look up with percentage of babies have birthdefects or dive vs. the15-30% chance it will work. If the percentage of ill effects to the baby are less than 3% i would do it.... Answered by Humberto Kurka 1 year ago.


Delalutin injections during pregnancy?
My doctor and I are discussing whether or not I should get weekly shots of delalutin to decrease my risk of preterm labor during my pregnancy. I am 20 weeks along....I had preterm labor at 28 weeks with my 1st pregnancy and at 30 weeks with my 2nd...with bedrest and oral medication I did carry both babies to full... Asked by Abby Vulgamore 1 year ago.

My doctor and I are discussing whether or not I should get weekly shots of delalutin to decrease my risk of preterm labor during my pregnancy. I am 20 weeks along....I had preterm labor at 28 weeks with my 1st pregnancy and at 30 weeks with my 2nd...with bedrest and oral medication I did carry both babies to full term. Does anyone have any information on delalutin? Answered by Jae Helfen 1 year ago.

I do not have any info on the drug, but I do believe that you carried to full term and yes it was probably a pain in the butt, but I think that you should be fine carrying full term again. If you think about injecting yourself with this drug then think about the baby and what the chemicals in the drug can do to your unborn baby. I take it your other two were healthy babies and then why take the chance of harming the third? I personally want my children to be as healthy and vibrant as possible. Do you know the long term effects of the drug on your child when it becomes an adult? If not then it would not be worth it at all to me. I am not trying to be mean at all, I am just trying to give you a little advise. Answered by Dacia Verburg 1 year ago.

I'm 29 weeks pregnant and have had my blood taken about 5 times so far during pregnancy and have had 2 or 3 injections. It's not over yet though!! I used to feel the same way about needles but have started to get braver. I had a miscarriage a few months before this pregnancy and had some blood tests, injections, and IVs at the hospital during that whole ordeal. Before that miscarriage I only had to deal with needles once every few years, lol. Now I'm slowly getting used to them. I guess when you're gonna be a mom it's a small price to pay, and we need to be tough for our children! I'm a wimp about pain but I'd die for my baby and I haven't even met him yet. Answered by Karren Nist 1 year ago.

My mother had this injection to carry me to term 35 years ago. The doctor and my parents were primarily concerned with be being a healthy, full-term baby and did not know, or were willing to risk the side effects the drug had on my brain. I have a congenital deformity in both feet, scoliosis, schizoaffective disorder, severe ADHD, and nerve issues (in my body, not brain). It has been linked to aggressiveness in children which, in my case, is due to the fact that I require a MUCH more extreme stimulus to feel emotions, be it happy, sad, pleasure, pain (both physical and emotional), satisfaction, etc. Because of this, interpersonal relationships are extremely difficult for me; I have even been diagnosed as a psychopath due to the fact that I only feel empathy, sympathy, guilt, or pleasure from extreme situations. (Psychopaths are considered to have no emotions; they feel no guilt, remorse, or empathy towards others; they only feel pleasure from extreme, usually inappropriate, situations involving a major adrenaline or endorphin release; they take pleasure in indiscriminately causing pain and harm. It is this last trait that I do not share or understand and changed my diagnosis.) Bottom line, seriously consider the life you are bringing into the world and whether you are willing to care for a special needs son or daughter from birth. My parents wanted a "trophy" child, not one that would require any actual work. This certainly worked against me as well, but the delalutin shaped my brain (and feet and spine) a bit wrong from the start. As a result I have had one lower leg amputation, attempted suicide at the age of 8, and will most likely be on disability for the rest of my life. Don't use that drug unless you are ready for a lifetime commitment to ensuring your child's emotional and physical health. Answered by Cody Yerty 1 year ago.


What do you think of Delalutin shots given weekly for help with trying to decrease the chance of preterm birth?
I was reading up on delalutin and read that it can cause still birth and birth defects. My doctor said its optional to get the shots. Also she said that there is a 15-30% chance that it will help. Im wondering your thoughts on this. Do you think it is worth the chances that can occur? I am 20 weeks, and did go... Asked by Denny Secky 1 year ago.

I was reading up on delalutin and read that it can cause still birth and birth defects. My doctor said its optional to get the shots. Also she said that there is a 15-30% chance that it will help. Im wondering your thoughts on this. Do you think it is worth the chances that can occur? I am 20 weeks, and did go into premature labor with my daughter (3 months). Its an important decision but I'm confused in what would be the best choice. Have you gotten these shots?? What is your outlook?? Thanks in advance. Answered by Harris Forcino 1 year ago.

i have never heard of it but it sounds like the risks may outweigh the benfits. I would look up with percentage of babies have birthdefects or dive vs. the15-30% chance it will work. If the percentage of ill effects to the baby are less than 3% i would do it.... Answered by Kurtis Kolm 1 year ago.


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