Application 201331
- Type
- ANDA
- Sponsor
- WOCKHARDT LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 002 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 150MG | No | No |
| 003 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 200MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 33261-449 | Bupropion Hydrochloride SR | Bupropion Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55648-101 | Bupropion Hydrochloride | Bupropion Hydrochloride | Wockhardt Limited | ANDA | Current |
| 55648-105 | Bupropion Hydrochloride | Bupropion Hydrochloride | Wockhardt Limited | ANDA | Current |
| 55648-107 | Bupropion Hydrochloride | Bupropion Hydrochloride | Wockhardt Limited | ANDA | Current |
| 64679-101 | Bupropion Hydrochloride | Bupropion Hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-101 | Bupropion Hydrochloride | Bupropion Hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-105 | Bupropion Hydrochloride | Bupropion Hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-105 | Bupropion Hydrochloride | Bupropion Hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-107 | Bupropion Hydrochloride | Bupropion Hydrochloride | Wockhardt USA LLC. | ANDA | Current |
| 64679-107 | Bupropion Hydrochloride | Bupropion Hydrochloride | Wockhardt USA LLC. | ANDA | Current |