Details for New Drug Application (NDA): 204083
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NDA 204083 describes DESVENLAFAXINE SUCCINATE, which is a drug marketed by Actavis Labs Fl, Alembic, Hikma, Intellipharmaceutics, Lupin Ltd, Norvium Bioscience, Rubicon, Yichang Humanwell, and Zydus Pharms, and is included in ten NDAs. It is available from twenty suppliers. Additional details are available on the DESVENLAFAXINE SUCCINATE profile page.
The generic ingredient in DESVENLAFAXINE SUCCINATE is desvenlafaxine succinate. There are sixteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the desvenlafaxine succinate profile page.
The generic ingredient in DESVENLAFAXINE SUCCINATE is desvenlafaxine succinate. There are sixteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the desvenlafaxine succinate profile page.
Summary for 204083
| Tradename: | DESVENLAFAXINE SUCCINATE |
| Applicant: | Hikma |
| Ingredient: | desvenlafaxine succinate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 204083
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESVENLAFAXINE SUCCINATE | desvenlafaxine succinate | TABLET, EXTENDED RELEASE;ORAL | 204083 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0401 | 0054-0401-13 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0401-13) |
| DESVENLAFAXINE SUCCINATE | desvenlafaxine succinate | TABLET, EXTENDED RELEASE;ORAL | 204083 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0401 | 0054-0401-22 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0401-22) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Feb 16, 2016 | TE: | AB | RLD: | No | ||||
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