Details for New Drug Application (NDA): 202260
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The generic ingredient in NORETHINDRONE 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 202260
Tradename: | NORETHINDRONE |
Applicant: | Amneal Pharms |
Ingredient: | norethindrone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 202260
Suppliers and Packaging for NDA: 202260
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NORETHINDRONE | norethindrone | TABLET;ORAL-28 | 202260 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1583 | 69238-1583-6 | 1 BLISTER PACK in 1 CARTON (69238-1583-6) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-28 | Strength | 0.35MG | ||||
Approval Date: | Aug 1, 2013 | TE: | RLD: | No |
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