Details for New Drug Application (NDA): 200980
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NDA 200980 describes NORETHINDRONE, which is a drug marketed by Amneal Pharms, Glenmark Generics, Lupin Ltd, Mylan Labs Ltd, Naari Pte Ltd, Novast Labs, Aurobindo Pharma Ltd, Barr, Barr Labs Inc, Glenmark Pharms Ltd, Dr Reddys Labs Sa, Mylan, Apotex, Xiromed, Watson Labs, Watson Pharms Teva, Watson Labs Teva, and Apil, and is included in sixty-three NDAs. It is available from seven suppliers. Additional details are available on the NORETHINDRONE profile page.
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.
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 200980
| Tradename: | NORETHINDRONE |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | norethindrone |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 200980
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NORETHINDRONE | norethindrone | TABLET;ORAL-28 | 200980 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7272 | 0378-7272-53 | 3 POUCH in 1 CARTON (0378-7272-53) / 1 BLISTER PACK in 1 POUCH (0378-7272-85) / 28 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.35MG | ||||
| Approval Date: | Jun 12, 2013 | TE: | AB2 | RLD: | No | ||||
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