Details for New Drug Application (NDA): 204083
NDA 204083 describes DESVENLAFAXINE SUCCINATE, which is a drug marketed by Actavis Labs Fl, Alembic, Hikma, Lupin, Macleods Pharms, Pharmobedient, Platinum, Rubicon Research, Yichang Humanwell, and Zydus Pharms, and is included in eleven 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 is one drug master file entry for this compound. Twenty-one 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 is one drug master file entry for this compound. Twenty-one 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. | 0054-0400 | 0054-0400-13 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0400-13) |
| DESVENLAFAXINE SUCCINATE | desvenlafaxine succinate | TABLET, EXTENDED RELEASE;ORAL | 204083 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0400 | 0054-0400-22 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0400-22) |
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 | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Feb 16, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Feb 16, 2016 | TE: | AB | RLD: | No | ||||
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