Application 204083
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | TABLET, EXTENDED RELEASE;ORAL | EQ 100MG BASE | No | No |
| 002 | DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | TABLET, EXTENDED RELEASE;ORAL | EQ 25MG BASE | No | No |
| 003 | DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | TABLET, EXTENDED RELEASE;ORAL | EQ 50MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0401 | Desvenlafaxine | Desvenlafaxine | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0401 | Desvenlafaxine | Desvenlafaxine | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0401 | Desvenlafaxine | Desvenlafaxine | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0401 | Desvenlafaxine | Desvenlafaxine | West-Ward Pharmaceuticals Corp. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32506 | ORIG | 2016-02-18 |