Application 203821
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS 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 |
|---|
| 68462-615 | nebivolol | nebivolol hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-616 | nebivolol | nebivolol hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-617 | nebivolol | nebivolol hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-618 | nebivolol | nebivolol hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 48564 | ORIG | 2017-05-30 |