Details for New Drug Application (NDA): 018168
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NDA 018168 describes DEMULEN 1/35-21, which is a drug marketed by Gd Searle Llc and is included in one NDA. Additional details are available on the DEMULEN 1/35-21 profile page.
The generic ingredient in DEMULEN 1/35-21 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.
The generic ingredient in DEMULEN 1/35-21 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 018168
| Tradename: | DEMULEN 1/35-21 |
| Applicant: | Gd Searle Llc |
| Ingredient: | ethinyl estradiol; ethynodiol diacetate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
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