Application 076938
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | TABLET;ORAL | EQ 400MG BASE | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-6406 | Moxifloxacin | Moxifloxacin | Major Pharmaceuticals | ANDA | Current |
| 0904-6406 | Moxifloxacin | Moxifloxacin | Major Pharmaceuticals | ANDA | Current |
| 0904-6406 | Moxifloxacin | Moxifloxacin | Major Pharmaceuticals | ANDA | Current |
| 50090-3147 | Moxifloxacin | Moxifloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-3147 | Moxifloxacin | Moxifloxacin | A-S Medication Solutions | ANDA | Current |
| 55111-112 | Moxifloxacin | Moxifloxacin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-112 | Moxifloxacin | Moxifloxacin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-112 | Moxifloxacin | Moxifloxacin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-112 | Moxifloxacin | Moxifloxacin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-112 | Moxifloxacin | Moxifloxacin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55700-638 | Moxifloxacin | Moxifloxacin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 63629-8357 | Moxifloxacin | Moxifloxacin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8357 | Moxifloxacin | Moxifloxacin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8357 | Moxifloxacin | Moxifloxacin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8357 | Moxifloxacin | Moxifloxacin | Bryant Ranch Prepack | ANDA | Current |
| 67296-1679 | Moxifloxacin | Moxifloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1679 | Moxifloxacin | Moxifloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 72789-233 | Moxifloxacin | Moxifloxacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-233 | Moxifloxacin | Moxifloxacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 8982 | ORIG | 2014-03-06 |