Details for New Drug Application (NDA): 013625
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NDA 013625 describes NORINYL 1+50 21-DAY, which is a drug marketed by Actavis Labs Ut Inc and is included in one NDA. Additional details are available on the NORINYL 1+50 21-DAY profile page.
The generic ingredient in NORINYL 1+50 21-DAY is mestranol; norethindrone. There are eleven drug master file entries for this compound. Additional details are available on the mestranol; norethindrone profile page.
The generic ingredient in NORINYL 1+50 21-DAY is mestranol; norethindrone. There are eleven drug master file entries for this compound. Additional details are available on the mestranol; norethindrone profile page.
Summary for 013625
| Tradename: | NORINYL 1+50 21-DAY |
| Applicant: | Actavis Labs Ut Inc |
| Ingredient: | mestranol; norethindrone |
| Patents: | 0 |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 0.05MG;1MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-20 | Strength | 0.1MG;2MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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