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Application 065283
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 002 | CLARITHROMYCIN | CLARITHROMYCIN | FOR SUSPENSION;ORAL | 125MG/5ML | No | No |
| 003 | CLARITHROMYCIN | CLARITHROMYCIN | FOR SUSPENSION;ORAL | 250MG/5ML | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0781-6022 | Clarithromycin | Clarithromycin | Sandoz Inc | ANDA | Current |
| 0781-6022 | Clarithromycin | Clarithromycin | Sandoz Inc | ANDA | Current |
| 0781-6022 | Clarithromycin | Clarithromycin | Sandoz Inc | ANDA | Current |
| 0781-6023 | Clarithromycin | Clarithromycin | Sandoz Inc | ANDA | Current |
| 0781-6023 | Clarithromycin | Clarithromycin | Sandoz Inc | ANDA | Current |
| 0781-6023 | Clarithromycin | Clarithromycin | Sandoz Inc | ANDA | Current |
| 50090-0994 | Clarithromycin | Clarithromycin | A-S Medication Solutions | ANDA | Current |
| 50090-0994 | Clarithromycin | Clarithromycin | A-S Medication Solutions | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23744 | ORIG | 2007-09-24 |