Application 211053
- Type
- ANDA
- Sponsor
- AUROBINDO 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 |
|---|
| 59651-137 | Nebivolol | Nebivolol | Aurobindo Pharma Limited | ANDA | Current |
| 59651-138 | Nebivolol | Nebivolol | Aurobindo Pharma Limited | ANDA | Current |
| 59651-139 | Nebivolol | Nebivolol | Aurobindo Pharma Limited | ANDA | Current |
| 59651-140 | Nebivolol | Nebivolol | Aurobindo Pharma Limited | ANDA | Current |
| 63629-9423 | Nebivolol | Nebivolol | Bryant Ranch Prepack | ANDA | Current |
| 63629-9424 | Nebivolol | Nebivolol | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 65856 | ORIG | 2021-01-07 |