Details for New Drug Application (NDA): 207535
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NDA 207535 describes NEXESTA FE, which is a drug marketed by Aurobindo Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the NEXESTA FE profile page.
The generic ingredient in NEXESTA FE is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
The generic ingredient in NEXESTA FE is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 207535
| Tradename: | NEXESTA FE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | ethinyl estradiol; norethindrone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207535
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEXESTA FE | ethinyl estradiol; norethindrone | TABLET;ORAL | 207535 | ANDA | Aurobindo Pharma Limited | 65862-926 | 65862-926-58 | 5 POUCH in 1 CARTON (65862-926-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK |
| NEXESTA FE | ethinyl estradiol; norethindrone | TABLET;ORAL | 207535 | ANDA | Aurobindo Pharma Limited | 65862-926 | 65862-926-87 | 1 POUCH in 1 CARTON (65862-926-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.035MG;0.4MG | ||||
| Approval Date: | Feb 2, 2017 | TE: | AB | RLD: | No | ||||
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