Application 076710
- Type
- ANDA
- Sponsor
- DR REDDYS LABS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEVOFLOXACIN | LEVOFLOXACIN | TABLET;ORAL | 250MG | No | No |
| 002 | LEVOFLOXACIN | LEVOFLOXACIN | TABLET;ORAL | 500MG | No | No |
| 003 | LEVOFLOXACIN | LEVOFLOXACIN | TABLET;ORAL | 750MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-6351 | Levofloxacin | Levofloxacin | Major Pharmaceuticals | ANDA | Current |
| 0904-6351 | Levofloxacin | Levofloxacin | Major Pharmaceuticals | ANDA | Current |
| 0904-6352 | Levofloxacin | Levofloxacin | Major Pharmaceuticals | ANDA | Current |
| 0904-6352 | Levofloxacin | Levofloxacin | Major Pharmaceuticals | ANDA | Current |
| 0904-6353 | Levofloxacin | Levofloxacin | Major Pharmaceuticals | ANDA | Current |
| 0904-6353 | Levofloxacin | Levofloxacin | Major Pharmaceuticals | ANDA | Current |
| 10544-245 | Levofloxacin | Levofloxacin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-558 | Levofloxacin | Levofloxacin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 50090-4928 | Levofloxacin | Levofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-4928 | Levofloxacin | Levofloxacin | A-S Medication Solutions | ANDA | Current |
| 51407-428 | Levofloxacin | Levofloxacin | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-428 | Levofloxacin | Levofloxacin | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-429 | Levofloxacin | Levofloxacin | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-429 | Levofloxacin | Levofloxacin | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-430 | Levofloxacin | Levofloxacin | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-430 | Levofloxacin | Levofloxacin | Golden State Medical Supply, Inc. | ANDA | Current |
| 55111-279 | Levofloxacin | Levofloxacin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-279 | Levofloxacin | Levofloxacin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-279 | Levofloxacin | Levofloxacin | Dr. Reddy's Laboratories | ANDA | Current |
| 55111-279 | Levofloxacin | Levofloxacin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-279 | Levofloxacin | Levofloxacin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-280 | Levofloxacin | Levofloxacin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-280 | Levofloxacin | Levofloxacin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-280 | Levofloxacin | Levofloxacin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-280 | Levofloxacin | Levofloxacin | Dr. Reddy's Laboratories | ANDA | Current |
| 55111-280 | Levofloxacin | Levofloxacin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-281 | Levofloxacin | Levofloxacin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-281 | Levofloxacin | Levofloxacin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-281 | Levofloxacin | Levofloxacin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-281 | Levofloxacin | Levofloxacin | Dr. Reddy's Laboratories | ANDA | Current |
| 55111-281 | Levofloxacin | Levofloxacin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55154-5897 | Levofloxacin | Levofloxacin | Cardinal Health 107, LLC | ANDA | Current |
| 55154-5897 | Levofloxacin | Levofloxacin | Cardinal Health | ANDA | Current |
| 55154-5897 | Levofloxacin | Levofloxacin | Cardinal Health | ANDA | Current |
| 55154-5897 | Levofloxacin | Levofloxacin | Cardinal Health | ANDA | Current |
| 55154-5898 | Levofloxacin | Levofloxacin | Cardinal Health | ANDA | Current |
| 55154-5898 | Levofloxacin | Levofloxacin | Cardinal Health | ANDA | Current |
| 55154-5898 | Levofloxacin | Levofloxacin | Cardinal Health | ANDA | Current |
| 55154-5898 | Levofloxacin | Levofloxacin | Cardinal Health 107, LLC | ANDA | Current |
| 55154-6898 | Levofloxacin | Levofloxacin | Cardinal Health | ANDA | Current |
| 55154-6898 | Levofloxacin | Levofloxacin | Cardinal Health | ANDA | Current |
| 67296-0977 | Levofloxacin | Levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0977 | Levofloxacin | Levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0977 | Levofloxacin | Levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1325 | Levofloxacin | Levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1325 | Levofloxacin | Levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1325 | Levofloxacin | Levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 68788-9268 | Levofloxacin | Levofloxacin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0453 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0453 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0453 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0453 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0453 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0453 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0932 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0932 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0932 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0932 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0932 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0932 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0932 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0932 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0967 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0967 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 71335-1277 | Levofloxacin | Levofloxacin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1277 | Levofloxacin | Levofloxacin | Bryant Ranch Prepack | ANDA | Current |