Application 065266
- Type
- ANDA
- Sponsor
- WOCKHARDT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLARITHROMYCIN | CLARITHROMYCIN | TABLET;ORAL | 250MG | No | No |
| 002 | CLARITHROMYCIN | CLARITHROMYCIN | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10544-522 | Clarithromycin | Clarithromycin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 33261-618 | Clarithromycin | Clarithromycin | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-631 | Clarithromycin | Clarithromycin | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 42254-188 | Clarithromycin | Clarithromycin | Rebel Distributors Corp | ANDA | Current |
| 55648-949 | Clarithromycin | Clarithromycin | Wockhardt Limited | ANDA | Current |
| 55648-954 | Clarithromycin | Clarithromycin | Wockhardt Limited | ANDA | Current |
| 64679-949 | Clarithromycin | Clarithromycin | Wockhardt USA LLC. | ANDA | Current |
| 64679-949 | Clarithromycin | Clarithromycin | Wockhardt USA LLC. | ANDA | Current |
| 64679-954 | Clarithromycin | Clarithromycin | Wockhardt USA LLC. | ANDA | Current |
| 64679-954 | Clarithromycin | Clarithromycin | Wockhardt USA LLC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23742 | ORIG | 2006-06-06 |