Details for New Drug Application (NDA): 018405
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NDA 018405 describes AYGESTIN, which is a drug marketed by Duramed Res and is included in one NDA. Additional details are available on the AYGESTIN profile page.
The generic ingredient in AYGESTIN is norethindrone acetate. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the norethindrone acetate profile page.
The generic ingredient in AYGESTIN is norethindrone acetate. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the norethindrone acetate profile page.
Summary for 018405
| Tradename: | AYGESTIN |
| Applicant: | Duramed Res |
| Ingredient: | norethindrone acetate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 21, 1982 | TE: | RLD: | Yes | |||||
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