Application 065155
- Type
- ANDA
- Sponsor
- TEVA
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 |
|---|---|---|---|---|---|
| 0093-7528 | Clarithromycin | Clarithromycin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7528 | Clarithromycin | Clarithromycin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7528 | Clarithromycin | Clarithromycin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7529 | Clarithromycin | Clarithromycin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23736 | ORIG | 2006-03-03 |