Application 206367
- Type
- ANDA
- Sponsor
- INVAGEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | TABLET;ORAL | EQ 2.5MG BASE | No | No |
| 002 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | TABLET;ORAL | EQ 5MG BASE | No | No |
| 003 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | TABLET;ORAL | EQ 10MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 76282-507 | Amlodipine besylate | Amlodipine besylate | Exelan Pharmaceuticals, Inc. | ANDA | Current |
| 76282-508 | Amlodipine besylate | Amlodipine besylate | Exelan Pharmaceuticals, Inc. | ANDA | Current |
| 76282-509 | Amlodipine besylate | Amlodipine besylate | Exelan Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32802 | ORIG | 2015-12-16 |