Application 201043
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10544-624 | Levofloxacin | Levofloxacin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 42708-122 | Levofloxacin | Levofloxacin | QPharma Inc | ANDA | Current |
| 42708-122 | Levofloxacin | Levofloxacin | QPharma Inc | ANDA | Current |
| 42708-122 | Levofloxacin | Levofloxacin | QPharma Inc | ANDA | Current |
| 43063-457 | Levofloxacin | Levofloxacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-457 | Levofloxacin | Levofloxacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-457 | Levofloxacin | Levofloxacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-457 | Levofloxacin | Levofloxacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-457 | Levofloxacin | Levofloxacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-457 | Levofloxacin | Levofloxacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-457 | Levofloxacin | Levofloxacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-457 | Levofloxacin | Levofloxacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-457 | Levofloxacin | Levofloxacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-457 | Levofloxacin | Levofloxacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-459 | Levofloxacin | Levofloxacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-459 | Levofloxacin | Levofloxacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-459 | Levofloxacin | Levofloxacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-459 | Levofloxacin | Levofloxacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-459 | Levofloxacin | Levofloxacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-1227 | Levofloxacin | Levofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-1228 | Levofloxacin | Levofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-1228 | Levofloxacin | Levofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-2498 | Levofloxacin | Levofloxacin | A-S Medication Solutions | ANDA | Current |
| 50090-2498 | Levofloxacin | Levofloxacin | A-S Medication Solutions | ANDA | Current |
| 52343-119 | Levofloxacin | Levofloxacin | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-119 | Levofloxacin | Levofloxacin | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-119 | Levofloxacin | Levofloxacin | LUCID PHARMA LLC | ANDA | Current |
| 52343-120 | Levofloxacin | Levofloxacin | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-120 | Levofloxacin | Levofloxacin | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-120 | Levofloxacin | Levofloxacin | LUCID PHARMA LLC | ANDA | Current |
| 52343-121 | Levofloxacin | Levofloxacin | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-121 | Levofloxacin | Levofloxacin | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-121 | Levofloxacin | Levofloxacin | LUCID PHARMA LLC | ANDA | Current |
| 53002-2350 | Levofloxacin | Levofloxacin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 57237-066 | Levofloxacin | Levofloxacin | Citron Pharma LLC | ANDA | Current |
| 57237-067 | Levofloxacin | Levofloxacin | Citron Pharma LLC | ANDA | Current |
| 57237-068 | Levofloxacin | Levofloxacin | Citron Pharma LLC | ANDA | Current |
| 61919-987 | LEVOFLOXACIN | LEVOFLOXACIN | DIRECT RX | ANDA | Current |
| 61919-987 | LEVOFLOXACIN | LEVOFLOXACIN | DIRECT RX | ANDA | Current |
| 64205-537 | Levofloxacin | Levofloxacin | ReadyMeds | ANDA | Current |
| 64980-366 | Levofloxacin | Levofloxacin | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-367 | Levofloxacin | Levofloxacin | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-368 | Levofloxacin | Levofloxacin | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 65862-536 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-536 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-536 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-536 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-536 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-536 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-536 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-536 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-537 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-537 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-537 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-537 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-537 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-537 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-537 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-537 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-538 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-538 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-538 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-538 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-538 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-538 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-538 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-538 | Levofloxacin | Levofloxacin | Aurobindo Pharma Limited | ANDA | Current |
| 67296-0897 | Levofloxacin | Levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0897 | Levofloxacin | Levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0897 | Levofloxacin | Levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0998 | Levofloxacin | Levofloxacin | RedPharm Drug, Inc. | ANDA | Current |
| 68071-4900 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4900 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4925 | Levofloxacin | Levofloxacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-9548 | Levofloxacin | Levofloxacin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9707 | Levofloxacin | Levofloxacin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0846 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0846 | Levofloxacin | Levofloxacin | REMEDYREPACK INC. | ANDA | Current |
| 71205-058 | Levofloxacin | Levofloxacin | Proficient Rx LP | ANDA | Current |
| 71205-058 | Levofloxacin | Levofloxacin | Proficient Rx LP | ANDA | Current |