Details for New Drug Application (NDA): 207505
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NDA 207505 describes AUROVELA FE 1/20, 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 AUROVELA FE 1/20 profile page.
The generic ingredient in AUROVELA FE 1/20 is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
The generic ingredient in AUROVELA FE 1/20 is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 207505
| Tradename: | AUROVELA FE 1/20 |
| Applicant: | Aurobindo Pharma |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207505
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AUROVELA FE 1/20 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 207505 | ANDA | Afaxys Pharma, LLC | 50102-228 | 50102-228-23 | 3 POUCH in 1 CARTON (50102-228-23) / 1 BLISTER PACK in 1 POUCH (50102-228-21) / 1 KIT in 1 BLISTER PACK |
| AUROVELA FE 1/20 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 207505 | ANDA | RPK Pharmaceuticals, Inc. | 53002-3711 | 53002-3711-1 | 1 KIT in 1 BLISTER PACK (53002-3711-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.02MG;1MG | ||||
| Approval Date: | Jun 16, 2017 | TE: | AB | RLD: | No | ||||
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