Details for New Drug Application (NDA): 018160
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The generic ingredient in DEMULEN 1/35-28 is ethinyl estradiol; ethynodiol diacetate. There are twenty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; ethynodiol diacetate profile page.
Summary for 018160
Tradename: | DEMULEN 1/35-28 |
Applicant: | Gd Searle Llc |
Ingredient: | ethinyl estradiol; ethynodiol diacetate |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
Expired US Patents for NDA 018160
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gd Searle Llc | DEMULEN 1/35-28 | ethinyl estradiol; ethynodiol diacetate | TABLET;ORAL-28 | 018160-001 | Approved Prior to Jan 1, 1982 | 3,483,221 | ⤷ Subscribe |
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