Application 207398
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AZITHROMYCIN | AZITHROMYCIN | TABLET;ORAL | EQ 500MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16571-696 | Azithromycin | Azithromycin | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-696 | Azithromycin | Azithromycin | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-696 | Azithromycin | Azithromycin | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-696 | Azithromycin | Azithromycin | Rising Pharma Holdings, Inc. | ANDA | Current |
| 50090-5366 | Azithromycin | Azithromycin | A-S Medication Solutions | ANDA | Current |
| 50090-5366 | Azithromycin | Azithromycin | A-S Medication Solutions | ANDA | Current |
| 50090-5366 | Azithromycin | Azithromycin | A-S Medication Solutions | ANDA | Current |
| 50090-5376 | Azithromycin | Azithromycin | A-S Medication Solutions | ANDA | Current |
| 50090-5376 | Azithromycin | Azithromycin | A-S Medication Solutions | ANDA | Current |
| 53002-0473 | Azithromycin | Azithromycin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 63629-8034 | Azithromycin | Azithromycin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8034 | Azithromycin | Azithromycin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8251 | Azithromycin | Azithromycin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8251 | Azithromycin | Azithromycin | Bryant Ranch Prepack | ANDA | Current |
| 65862-642 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-642 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-642 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-642 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-642 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 68071-4976 | Azithromycin | Azithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4976 | Azithromycin | Azithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5058 | Azithromycin | Azithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5058 | Azithromycin | Azithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5082 | Azithromycin | Azithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5082 | Azithromycin | Azithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5170 | Azithromycin | Azithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5170 | Azithromycin | Azithromycin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7598 | Azithromycin | Azithromycin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7598 | Azithromycin | Azithromycin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7598 | Azithromycin | Azithromycin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-3508 | Azithromycin | Azithromycin | REMEDYREPACK INC. | ANDA | Current |
| 71205-519 | Azithromycin | Azithromycin | Proficient Rx LP | ANDA | Current |
| 71205-519 | Azithromycin | Azithromycin | Proficient Rx LP | ANDA | Current |
| 71335-1252 | Azithromycin | Azithromycin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1252 | Azithromycin | Azithromycin | Bryant Ranch Prepack | ANDA | Current |
| 72189-015 | AZITHROMYCIN | AZITHROMYCIN | Direct_Rx | ANDA | Current |
| 72189-015 | AZITHROMYCIN | AZITHROMYCIN | Direct_Rx | ANDA | Current |