Details for New Drug Application (NDA): 207304
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NDA 207304 describes INCASSIA, which is a drug marketed by Aurobindo Pharma and is included in one NDA. It is available from three suppliers. Additional details are available on the INCASSIA profile page.
The generic ingredient in INCASSIA is norethindrone. There are twenty-six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the norethindrone profile page.
The generic ingredient in INCASSIA is norethindrone. There are twenty-six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the norethindrone profile page.
Summary for 207304
| Tradename: | INCASSIA |
| Applicant: | Aurobindo Pharma |
| Ingredient: | norethindrone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207304
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INCASSIA | norethindrone | TABLET;ORAL-28 | 207304 | ANDA | Afaxys Pharma, LLC | 50102-300 | 50102-300-13 | 3 PACKAGE in 1 CARTON (50102-300-13) / 1 BLISTER PACK in 1 PACKAGE (50102-300-11) / 28 TABLET in 1 BLISTER PACK (50102-300-01) |
| INCASSIA | norethindrone | TABLET;ORAL-28 | 207304 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1793 | 53002-1793-1 | 1 BLISTER PACK in 1 PACKAGE (53002-1793-1) / 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: | Sep 23, 2016 | TE: | AB1 | RLD: | No | ||||
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