Details for New Drug Application (NDA): 207504
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NDA 207504 describes AUROVELA 24 FE, 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 24 FE profile page.
The generic ingredient in AUROVELA 24 FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
The generic ingredient in AUROVELA 24 FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 207504
| Tradename: | AUROVELA 24 FE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207504
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AUROVELA 24 FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 207504 | ANDA | Afaxys Pharma, LLC | 50102-224 | 50102-224-23 | 3 POUCH in 1 CARTON (50102-224-23) / 1 BLISTER PACK in 1 POUCH (50102-224-21) / 1 KIT in 1 BLISTER PACK |
| AUROVELA 24 FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 207504 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1789 | 53002-1789-1 | 1 KIT in 1 BLISTER PACK (53002-1789-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.02MG;1MG | ||||
| Approval Date: | Jun 15, 2017 | TE: | AB | RLD: | No | ||||
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