Details for New Drug Application (NDA): 204003
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NDA 204003 describes DESVENLAFAXINE SUCCINATE, which is a drug marketed by Actavis Labs Fl, Alembic, Hikma, Lupin Ltd, Macleods Pharms Ltd, Medicap Labs, Pharmobedient, Rubicon Research, Yichang Humanwell, and Zydus Pharms, and is included in ten NDAs. It is available from nineteen 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 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 suppliers are listed for this compound. Additional details are available on the desvenlafaxine succinate profile page.
Summary for 204003
| Tradename: | DESVENLAFAXINE SUCCINATE |
| Applicant: | Alembic |
| Ingredient: | desvenlafaxine succinate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 204003
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESVENLAFAXINE SUCCINATE | desvenlafaxine succinate | TABLET, EXTENDED RELEASE;ORAL | 204003 | ANDA | Alembic Pharmaceuticals Limited | 46708-540 | 46708-540-10 | 100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-540-10) |
| DESVENLAFAXINE SUCCINATE | desvenlafaxine succinate | TABLET, EXTENDED RELEASE;ORAL | 204003 | ANDA | Alembic Pharmaceuticals Limited | 46708-540 | 46708-540-17 | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-540-17) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Jun 29, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Jun 29, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Sep 14, 2018 | TE: | AB | RLD: | No | ||||
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