Details for New Drug Application (NDA): 204020
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NDA 204020 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 204020
| Tradename: | DESVENLAFAXINE SUCCINATE |
| Applicant: | Zydus Pharms |
| Ingredient: | desvenlafaxine succinate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 204020
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESVENLAFAXINE SUCCINATE | desvenlafaxine succinate | TABLET, EXTENDED RELEASE;ORAL | 204020 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-105 | 68382-105-06 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-105-06) |
| DESVENLAFAXINE SUCCINATE | desvenlafaxine succinate | TABLET, EXTENDED RELEASE;ORAL | 204020 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-105 | 68382-105-16 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-105-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Oct 11, 2017 | 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: | Oct 11, 2017 | 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: | Nov 30, 2022 | TE: | AB | RLD: | No | ||||
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