Application Information

This drug has been submitted to the FDA under the reference 011719/011.

Names and composition

"METHOTREXATE PRESERVATIVE FREE" is the commercial name of a drug composed of METHOTREXATE SODIUM.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
011719/011 METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 2.5GM BASE per 100ML (EQ 25MG BASE per ML)
011719/013 METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 500MG BASE per 20ML (EQ 25MG BASE per ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
011719/014 METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 20MG BASE per 2ML (EQ 10MG BASE per ML)
040265/001 METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
040266/001 METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 1GM BASE per VIAL
200171/001 METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 100MG BASE per 4ML (EQ 25MG BASE per ML)

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
008085/002 METHOTREXATE SODIUM METHOTREXATE SODIUM TABLET/ORAL EQ 2.5MG BASE
011719/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 20MG BASE per VIAL
011719/003 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per VIAL
011719/004 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 2.5MG BASE per ML
011719/005 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
011719/006 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 100MG BASE per VIAL
011719/007 METHOTREXATE LPF METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
011719/009 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 1GM BASE per VIAL
011719/010 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per 2ML (EQ 25MG BASE per ML)
011719/011 METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 2.5GM BASE per 100ML (EQ 25MG BASE per ML)
011719/012 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 1GM BASE per 40ML (EQ 25MG BASE per ML)
011719/013 METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 500MG BASE per 20ML (EQ 25MG BASE per ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
011719/014 METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 20MG BASE per 2ML (EQ 10MG BASE per ML)
040054/001 METHOTREXATE SODIUM METHOTREXATE SODIUM TABLET/ORAL EQ 2.5MG BASE
040233/001 METHOTREXATE SODIUM METHOTREXATE SODIUM TABLET/ORAL EQ 2.5MG BASE
040263/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per 2ML (EQ 25MG BASE per ML)
040263/002 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 250MG BASE per 10ML (EQ 25MG BASE per ML)
040265/001 METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
040266/001 METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 1GM BASE per VIAL
040385/001 TREXALL METHOTREXATE SODIUM TABLET/ORAL EQ 5MG BASE
040385/002 TREXALL METHOTREXATE SODIUM TABLET/ORAL EQ 7.5MG BASE
040385/003 TREXALL METHOTREXATE SODIUM TABLET/ORAL EQ 10MG BASE
040385/004 TREXALL METHOTREXATE SODIUM TABLET/ORAL EQ 15MG BASE
040632/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 1GM BASE per VIAL
040716/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 1GM BASE per 40ML (EQ 25MG BASE per ML)
040767/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per 2ML (EQ 25MG BASE per ML)
040768/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 250MG BASE per 10ML (EQ 25MG BASE per ML)
040843/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 1GM BASE per 40ML (EQ 25MG BASE per ML)
040850/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per 2ML (EQ 25MG BASE per ML)
040853/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 250MG per 10ML (EQ 25MG BASE per ML)
081099/001 METHOTREXATE SODIUM METHOTREXATE SODIUM TABLET/ORAL EQ 2.5MG BASE
081235/001 METHOTREXATE SODIUM METHOTREXATE SODIUM TABLET/ORAL EQ 2.5MG BASE
081242/001 FOLEX PFS METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
086358/001 MEXATE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 20MG BASE per VIAL
086358/002 MEXATE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per VIAL
086358/003 MEXATE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 100MG BASE per VIAL
086358/004 MEXATE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 250MG BASE per VIAL
087695/001 FOLEX METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per VIAL
087695/002 FOLEX METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per VIAL
087695/003 FOLEX METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 100MG BASE per VIAL
088648/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
088760/001 MEXATE-AQ METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
088935/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 20MG BASE per VIAL
088936/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per VIAL
088937/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 100MG BASE per VIAL
088954/001 FOLEX METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 250MG BASE per VIAL
089158/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
089161/001 ABITREXATE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
089180/001 FOLEX PFS METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
089263/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
089293/001 METHOTREXATE SODIUM METHOTREXATE SODIUM Injectable/ Injection EQ 20MG BASE per VIAL
089294/001 METHOTREXATE SODIUM METHOTREXATE SODIUM Injectable/ Injection EQ 50MG BASE per VIAL
089295/001 METHOTREXATE SODIUM METHOTREXATE SODIUM Injectable/ Injection EQ 100MG BASE per VIAL
089296/001 METHOTREXATE SODIUM METHOTREXATE SODIUM Injectable/ Injection EQ 250MG BASE per VIAL
089308/001 METHOTREXATE SODIUM METHOTREXATE SODIUM Injectable/ Injection EQ 25MG BASE per ML
089309/001 METHOTREXATE SODIUM METHOTREXATE SODIUM Injectable/ Injection EQ 25MG BASE per ML
089322/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
089323/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 2.5MG BASE per ML
089340/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per 2ML (EQ 25MG BASE per ML)
089341/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 100MG BASE per 4ML (EQ 25MG BASE per ML)
089342/001 METHOTREXATE SODIUM METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 200MG BASE per 8ML (EQ 25MG BASE per ML)
089343/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 250MG BASE per 10ML (EQ 25MG BASE per ML)
089354/001 ABITREXATE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per VIAL
089355/001 ABITREXATE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 100MG BASE per VIAL
089356/001 ABITREXATE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 250MG BASE per VIAL
089887/001 MEXATE-AQ PRESERVED METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 25MG BASE per ML
090029/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 1GM BASE per 40ML (EQ 25MG BASE per ML)
090039/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per 2ML (EQ 25MG BASE per ML)
090039/002 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 250MG BASE per 10ML (EQ 25MG BASE per ML)
200171/001 METHOTREXATE PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 100MG BASE per 4ML (EQ 25MG BASE per ML)
201529/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 50MG BASE per 2ML (EQ 25MG BASE per ML)
201529/002 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 100MG BASE per 4ML (EQ 25MG BASE per ML)
201529/003 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 200MG BASE per 8ML (EQ 25MG BASE per ML)
201529/004 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 250MG BASE per 10ML (EQ 25MG BASE per ML)
201530/001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM INJECTABLE/INJECTION EQ 1GM BASE per 40ML (EQ 25MG BASE per ML)
201749/001 METHOTREXATE SODIUM METHOTREXATE SODIUM TABLET/ORAL EQ 2.5MG BASE
207812/001 METHOTREXATE SODIUM METHOTREXATE SODIUM TABLET/ORAL EQ 2.5MG BASE
208400/001 XATMEP METHOTREXATE SODIUM SOLUTION/ORAL EQ 2.5MG BASE per ML

Ask a doctor

A licensed doctor will try to answer your question for free as quickly as possible. Free of charge during the beta period.

Answered questions

Children's cancer drug shortage is unclear, what do you think?
I was wondering what people think of this. Obviously this is a big problem. Children should not have to suffer. Why is the drug in short supply? Asked by Patrick Nogle 1 year ago.

It's preservative-free methotrexate, used in treatment of acute lymphoblastic leukemia, the most common kind of childhood cancer. It's a big problem and could have devastating effects if it's not fixed soon. Kids with ALL get intrathecal chemo (injected into the spinal fluid) regularly through treatment, over 2.5-3.5 years. They also get IV methotrexate at various times during treatment. Regular methotrexate with preservatives absolutely cannot be used intrathecally. As far as IV, we don't know the effects of the MTX with preservatives on children. The problem is that there is currenly one company making the preservative-free MTX in the United States, and the FDA will not allow it to be imported from other countries. It's an old drug (they were using it back in the 1960s for ALL) and therefore, does not bring in much money for drug companies and it's not worth producing from a profit standpoint. It's been in the news in the last two weeks or so (on the national nightly news, in newspapers, etc.) but we've been dealing with this for a while now. Right now, we're delaying some IV methotrexate admissions (we also use IV MTX for other diagnoses, including osteosarcoma), and for intrathecals, we are grouping them so as not to waste (once a vial is opened, it must be used within 24 hours and not held for another two days.) But it's a valid concern and it's such a mainstay of ALL treatment that the results could be really, really bad. Answered by Thomasena Rimson 1 year ago.

I don't know about the children's drug shortage. I do know about the fake avastin that's been given to cancer patients. Answered by Gertrude Georgales 1 year ago.

No one should have to suffer. Which drug is it? I'm there must be a story about is somewhere that will explain it. Answered by Clark Wayman 1 year ago.


Children's cancer drug shortage is unclear, what do you think?
I was wondering what people think of this. Obviously this is a big problem. Children should not have to suffer. Why is the drug in short supply? Asked by Piper Lychwala 1 year ago.

It's preservative-free methotrexate, used in treatment of acute lymphoblastic leukemia, the most common kind of childhood cancer. It's a big problem and could have devastating effects if it's not fixed soon. Kids with ALL get intrathecal chemo (injected into the spinal fluid) regularly through treatment, over 2.5-3.5 years. They also get IV methotrexate at various times during treatment. Regular methotrexate with preservatives absolutely cannot be used intrathecally. As far as IV, we don't know the effects of the MTX with preservatives on children. The problem is that there is currenly one company making the preservative-free MTX in the United States, and the FDA will not allow it to be imported from other countries. It's an old drug (they were using it back in the 1960s for ALL) and therefore, does not bring in much money for drug companies and it's not worth producing from a profit standpoint. It's been in the news in the last two weeks or so (on the national nightly news, in newspapers, etc.) but we've been dealing with this for a while now. Right now, we're delaying some IV methotrexate admissions (we also use IV MTX for other diagnoses, including osteosarcoma), and for intrathecals, we are grouping them so as not to waste (once a vial is opened, it must be used within 24 hours and not held for another two days.) But it's a valid concern and it's such a mainstay of ALL treatment that the results could be really, really bad. Answered by Gertrud Zampella 1 year ago.

I don't know about the children's drug shortage. I do know about the fake avastin that's been given to cancer patients. Answered by Joslyn Youkhana 1 year ago.

No one should have to suffer. Which drug is it? I'm there must be a story about is somewhere that will explain it. Answered by Kacie Oberhelman 1 year ago.


Children's cancer drug shortage is unclear, what do you think?
I was wondering what people think of this. Obviously this is a big problem. Children should not have to suffer. Why is the drug in short supply? Asked by Dallas Maschak 1 year ago.

It's preservative-free methotrexate, used in treatment of acute lymphoblastic leukemia, the most common kind of childhood cancer. It's a big problem and could have devastating effects if it's not fixed soon. Kids with ALL get intrathecal chemo (injected into the spinal fluid) regularly through treatment, over 2.5-3.5 years. They also get IV methotrexate at various times during treatment. Regular methotrexate with preservatives absolutely cannot be used intrathecally. As far as IV, we don't know the effects of the MTX with preservatives on children. The problem is that there is currenly one company making the preservative-free MTX in the United States, and the FDA will not allow it to be imported from other countries. It's an old drug (they were using it back in the 1960s for ALL) and therefore, does not bring in much money for drug companies and it's not worth producing from a profit standpoint. It's been in the news in the last two weeks or so (on the national nightly news, in newspapers, etc.) but we've been dealing with this for a while now. Right now, we're delaying some IV methotrexate admissions (we also use IV MTX for other diagnoses, including osteosarcoma), and for intrathecals, we are grouping them so as not to waste (once a vial is opened, it must be used within 24 hours and not held for another two days.) But it's a valid concern and it's such a mainstay of ALL treatment that the results could be really, really bad. Answered by Elena Mero 1 year ago.

I don't know about the children's drug shortage. I do know about the fake avastin that's been given to cancer patients. Answered by Russell Robbie 1 year ago.

No one should have to suffer. Which drug is it? I'm there must be a story about is somewhere that will explain it. Answered by Macy Bradburn 1 year ago.


Children's cancer drug shortage is unclear, what do you think?
I was wondering what people think of this. Obviously this is a big problem. Children should not have to suffer. Why is the drug in short supply? Asked by Dionne Mortellaro 1 year ago.

It's preservative-free methotrexate, used in treatment of acute lymphoblastic leukemia, the most common kind of childhood cancer. It's a big problem and could have devastating effects if it's not fixed soon. Kids with ALL get intrathecal chemo (injected into the spinal fluid) regularly through treatment, over 2.5-3.5 years. They also get IV methotrexate at various times during treatment. Regular methotrexate with preservatives absolutely cannot be used intrathecally. As far as IV, we don't know the effects of the MTX with preservatives on children. The problem is that there is currenly one company making the preservative-free MTX in the United States, and the FDA will not allow it to be imported from other countries. It's an old drug (they were using it back in the 1960s for ALL) and therefore, does not bring in much money for drug companies and it's not worth producing from a profit standpoint. It's been in the news in the last two weeks or so (on the national nightly news, in newspapers, etc.) but we've been dealing with this for a while now. Right now, we're delaying some IV methotrexate admissions (we also use IV MTX for other diagnoses, including osteosarcoma), and for intrathecals, we are grouping them so as not to waste (once a vial is opened, it must be used within 24 hours and not held for another two days.) But it's a valid concern and it's such a mainstay of ALL treatment that the results could be really, really bad. Answered by Jene Detro 1 year ago.

I don't know about the children's drug shortage. I do know about the fake avastin that's been given to cancer patients. Answered by Eleni Cambell 1 year ago.

No one should have to suffer. Which drug is it? I'm there must be a story about is somewhere that will explain it. Answered by Paul Mazzone 1 year ago.


Children's cancer drug shortage is unclear, what do you think?
I was wondering what people think of this. Obviously this is a big problem. Children should not have to suffer. Why is the drug in short supply? Asked by Fatima Pies 1 year ago.

It's preservative-free methotrexate, used in treatment of acute lymphoblastic leukemia, the most common kind of childhood cancer. It's a big problem and could have devastating effects if it's not fixed soon. Kids with ALL get intrathecal chemo (injected into the spinal fluid) regularly through treatment, over 2.5-3.5 years. They also get IV methotrexate at various times during treatment. Regular methotrexate with preservatives absolutely cannot be used intrathecally. As far as IV, we don't know the effects of the MTX with preservatives on children. The problem is that there is currenly one company making the preservative-free MTX in the United States, and the FDA will not allow it to be imported from other countries. It's an old drug (they were using it back in the 1960s for ALL) and therefore, does not bring in much money for drug companies and it's not worth producing from a profit standpoint. It's been in the news in the last two weeks or so (on the national nightly news, in newspapers, etc.) but we've been dealing with this for a while now. Right now, we're delaying some IV methotrexate admissions (we also use IV MTX for other diagnoses, including osteosarcoma), and for intrathecals, we are grouping them so as not to waste (once a vial is opened, it must be used within 24 hours and not held for another two days.) But it's a valid concern and it's such a mainstay of ALL treatment that the results could be really, really bad. Answered by Blake Rosebaugh 1 year ago.

I don't know about the children's drug shortage. I do know about the fake avastin that's been given to cancer patients. Answered by Sherice Youkhana 1 year ago.

No one should have to suffer. Which drug is it? I'm there must be a story about is somewhere that will explain it. Answered by Zenobia Imboden 1 year ago.


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