Application 209201
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AZITHROMYCIN | AZITHROMYCIN | FOR SUSPENSION;ORAL | EQ 100MG BASE/5ML | No | No |
| 002 | AZITHROMYCIN | AZITHROMYCIN | FOR SUSPENSION;ORAL | EQ 200MG BASE/5ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-5283 | Azithromycin | Azithromycin | A-S Medication Solutions | ANDA | Current |
| 59651-007 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-007 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-007 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-007 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-007 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-007 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-007 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-007 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-008 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-008 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-008 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-008 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-008 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-008 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-008 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-008 | Azithromycin | Azithromycin | Aurobindo Pharma Limited | ANDA | Current |
| 68788-8222 | Azithromycin | Azithromycin | Preferred Pharmaceuticals Inc. | ANDA | Current |