Details for New Drug Application (NDA): 206886
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NDA 206886 describes AFIRMELLE, 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 AFIRMELLE profile page.
The generic ingredient in AFIRMELLE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
The generic ingredient in AFIRMELLE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 206886
| Tradename: | AFIRMELLE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | ethinyl estradiol; levonorgestrel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206886
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AFIRMELLE | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 206886 | ANDA | Afaxys Pharma, LLC | 50102-220 | 50102-220-23 | 3 POUCH in 1 CARTON (50102-220-23) / 1 BLISTER PACK in 1 POUCH (50102-220-21) / 1 KIT in 1 BLISTER PACK |
| AFIRMELLE | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 206886 | ANDA | RPK Pharmaceuticals, Inc. | 53002-2692 | 53002-2692-1 | 1 BLISTER PACK in 1 PACKAGE (53002-2692-1) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.02MG;0.1MG | ||||
| Approval Date: | Nov 14, 2016 | TE: | AB1 | RLD: | No | ||||
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