Details for New Drug Application (NDA): 201483
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NDA 201483 describes NORETHINDRONE, which is a drug marketed by Amneal Pharms, Glenmark Pharms Ltd, Lupin Ltd, Naari Pte Ltd, Novast Labs, Xiromed, Aurobindo Pharma Ltd, Barr, Barr Labs Inc, Dr Reddys Labs Sa, Apotex, Watson Labs, Watson Pharms Teva, Mylan Labs Ltd, Watson Labs Teva, and Teva Branded Pharm, and is included in sixty-three NDAs. It is available from nine 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 201483
| Tradename: | NORETHINDRONE |
| Applicant: | Xiromed |
| Ingredient: | norethindrone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 201483
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NORETHINDRONE | norethindrone | TABLET;ORAL-28 | 201483 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7292 | 0378-7292-53 | 3 POUCH in 1 CARTON (0378-7292-53) / 1 BLISTER PACK in 1 POUCH (0378-7292-85) / 28 TABLET in 1 BLISTER PACK |
| NORETHINDRONE | norethindrone | TABLET;ORAL-28 | 201483 | ANDA | REMEDYREPACK INC. | 70518-4211 | 70518-4211-0 | 3 POUCH in 1 CARTON (70518-4211-0) / 1 BLISTER PACK in 1 POUCH / 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 24, 2013 | TE: | AB1 | RLD: | No | ||||
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