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Application 213349
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | TABLET;ORAL | EQ 2.5MG BASE | No | No |
| 002 | NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE | No | No |
| 003 | NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE | No | No |
| 004 | NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | TABLET;ORAL | EQ 20MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 27241-179 | Nebivolol | Nebivolol | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-180 | Nebivolol | Nebivolol | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-181 | Nebivolol | Nebivolol | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-182 | Nebivolol | Nebivolol | Ajanta Pharma USA Inc. | ANDA | Current |