Application 065145
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CLARITHROMYCIN | CLARITHROMYCIN | TABLET, EXTENDED RELEASE;ORAL | 500MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-2805 | clarithromycin | clarithromycin | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2805 | clarithromycin | clarithromycin | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2805 | clarithromycin | clarithromycin | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2805 | clarithromycin | clarithromycin | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2805 | clarithromycin | clarithromycin | Actavis Pharma, Inc. | ANDA | Current |
| 42291-263 | clarithromycin | clarithromycin | AvKARE, Inc. | ANDA | Current |
| 43063-520 | clarithromycin | clarithromycin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-520 | clarithromycin | clarithromycin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-520 | clarithromycin | clarithromycin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-565 | clarithromycin | clarithromycin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-565 | clarithromycin | clarithromycin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-565 | clarithromycin | clarithromycin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-565 | clarithromycin | clarithromycin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-1410 | clarithromycin | clarithromycin | A-S Medication Solutions | ANDA | Current |
| 50090-1410 | clarithromycin | clarithromycin | A-S Medication Solutions | ANDA | Current |
| 55695-018 | clarithromycin | clarithromycin | Department of State Health Services, Pharmacy Branch | ANDA | Current |
| 66336-429 | clarithromycin | clarithromycin | Dispensing Solutions, Inc. | ANDA | Current |
| 67296-1072 | clarithromycin | clarithromycin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1072 | clarithromycin | clarithromycin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1072 | clarithromycin | clarithromycin | RedPharm Drug, Inc. | ANDA | Current |
| 68788-6887 | clarithromycin | clarithromycin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6887 | clarithromycin | clarithromycin | Preferred Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23735 | ORIG | 2006-03-03 |