Details for New Drug Application (NDA): 091209
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NDA 091209 describes NORETHINDRONE, which is a drug marketed by Amneal Pharms, Glenmark Pharms Ltd, Lupin Ltd, Mylan Labs Ltd, Naari Pte Ltd, Novast Labs, Aurobindo Pharma Ltd, Barr, Barr Labs Inc, Dr Reddys Labs Sa, Mylan, Apotex, Xiromed, Watson Labs, Watson Pharms Teva, Watson Labs Teva, and Teva Branded Pharm, 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 091209
| Tradename: | NORETHINDRONE |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | norethindrone |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 091209
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NORETHINDRONE | norethindrone | TABLET;ORAL-28 | 091209 | ANDA | Proficient Rx LP | 63187-748 | 63187-748-28 | 28 TABLET in 1 POUCH (63187-748-28) |
| NORETHINDRONE | norethindrone | TABLET;ORAL-28 | 091209 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-305 | 68462-305-29 | 3 POUCH in 1 CARTON (68462-305-29) / 28 TABLET in 1 POUCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.35MG | ||||
| Approval Date: | Jul 22, 2010 | TE: | AB2 | RLD: | No | ||||
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