Application Information

This drug has been submitted to the FDA under the reference 018160/001.

Names and composition

"DEMULEN 1/35-28" is the commercial name of a drug composed of ETHINYL ESTRADIOL and ETHYNODIOL DIACETATE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
018160/001 DEMULEN 1/35-28 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE TABLET/ORAL-28 0.035MG and 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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
016927/001 DEMULEN 1/50-21 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE TABLET/ORAL-21 0.05MG and 1MG
016936/001 DEMULEN 1/50-28 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE TABLET/ORAL-28 0.05MG and 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
018160/001 DEMULEN 1/35-28 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE TABLET/ORAL-28 0.035MG and 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
018168/001 DEMULEN 1/35-21 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE TABLET/ORAL-21 0.035MG and 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
072720/001 ZOVIA 1/35E-21 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE TABLET/ORAL-21 0.035MG and 1MG
072721/001 ZOVIA 1/35E-28 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE TABLET/ORAL-28 0.035MG and 1MG
072722/001 ZOVIA 1/50E-21 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE TABLET/ORAL-21 0.05MG and 1MG
072723/001 ZOVIA 1/50E-28 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE TABLET/ORAL-28 0.05MG and 1MG
076785/001 KELNOR ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE TABLET/ORAL-28 0.035MG and 1MG
204703/001 ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE TABLET/ORAL-28 0.035MG and 1MG
204704/001 ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE TABLET/ORAL-28 0.05MG and 1MG

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Answered questions

Has anyone ever taken Zovia 1/35 28 birth control?
I was prescribed Zovia 1/35 28 birth control (generic for Demulen) after being diagnosed with PCOS. I have never taken birth control yet and I'm going to start this one soon. Has anyone ever taken it? How was it? Were there any good or bad side effects? Asked by Evelina Aulds 1 year ago.

All BC pills have some side effects (pretty similar overall to be honest), and it varies from woman to woman. So it's not that useful to ask for individual responses, though I understand that the human touch is reassuring. The list of side effects is as follows. The ones that in the "stop using" category are very rare, the ones in the "less serious" category are more common of course. They are all pretty similar no matter what brand of BC you pick.... Stop using this medication and call your doctor at once if you have any of these serious side effects: - sudden numbness or weakness, especially on one side of the body; - sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance; - chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; - a change in the pattern or severity of migraine headaches; - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); - swelling in your hands, ankles, or feet; - a breast lump; or - symptoms of depression (sleep problems, weakness, mood changes). Less serious side effects may include: - mild nausea, vomiting, bloating, stomach cramps; breast pain, tenderness, or swelling; - freckles or darkening of facial skin; - increased hair growth, loss of scalp hair; - changes in weight or appetite; - problems with contact lenses; - vaginal itching or discharge; - changes in your menstrual periods, decreased sex drive; or - headache, nervousness, dizziness, tired feeling. Answered by Porsche Mciver 1 year ago.


Do I have to start my Birth Control the first Sunday after my period begins?
Correction: I was prescribed the generic for Demulen, which is called ZOVIA 1/35 (28). Asked by Myrle Marek 1 year ago.

I was diagnosed with PCOS two months ago. My gynecologist put me on Demulen 1/35 (28) Birth Control to control my periods and PCOS symptoms. This will be the first time I am ever taking it. He told me to start the BC on the first Sunday that I get my period, even if I get my period the day before (on a Saturday). Well, I got my period on Thursday night after taking 7 days of Progesterone. I hadn't had a period in over 2 months and my doctor wanted to make sure I had one before taking the pill. I'm supposed to start the BC today because it is the first Sunday, but I'm thinking I should wait until next Sunday because I still have my period right now and it's pretty heavy. Also, if I do take it during my period, do I begin with the inactive pills or do I take the active pills? Answered by Maira Ormond 1 year ago.

you should start taking it the first sunday after your period begins....so if you get your period between monday and saturday, take the active pill on sunday. If you take the pills on a different day you can mess up your cycle. once you get into the swing of it. you will take the active pills in between periods, and the in- active pills during your period. Answered by Hortencia Lovec 1 year ago.

What you are saying doesn't make any sense. You should call your doctor to have the directions read to you clearly. When I started taking birth control pills, I was told to take the first active pill on the first day of your period within 24 hours. The thing is you have to take them at a fixed time, one pill a day. For an example, you would take it at 5pm everyday. You have to decide on what time would be best to take the pill. Answered by Retta Matanane 1 year ago.


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