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Application 203685
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 75MG | No | No |
| 002 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 150MG | No | No |
| 003 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 27241-033 | Irbesartan | Irbesartan | Ajanta Pharma Limited | ANDA | Current |
| 27241-035 | Irbesartan | Irbesartan | Ajanta Pharma Limited | ANDA | Current |
| 27241-036 | Irbesartan | Irbesartan | Ajanta Pharma Limited | ANDA | Current |