Application 065178
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLARITHROMYCIN | CLARITHROMYCIN | TABLET;ORAL | 500MG | No | No |
| 002 | CLARITHROMYCIN | CLARITHROMYCIN | TABLET;ORAL | 250MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0036 | Clarithromycin | clarithromycin | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0037 | Clarithromycin | clarithromycin | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0037 | Clarithromycin | clarithromycin | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 10544-952 | Clarithromycin | clarithromycin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 63629-2887 | Clarithromycin | clarithromycin | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23737 | ORIG | 2006-03-03 |