Application 078855
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FELODIPINE | FELODIPINE | TABLET, EXTENDED RELEASE;ORAL | 2.5MG | No | No |
| 002 | FELODIPINE | FELODIPINE | TABLET, EXTENDED RELEASE;ORAL | 5MG | No | No |
| 003 | FELODIPINE | FELODIPINE | TABLET, EXTENDED RELEASE;ORAL | 10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-5011 | Felodipine | Felodipine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5012 | Felodipine | Felodipine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5013 | Felodipine | Felodipine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0615-6572 | Felodipine | Felodipine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-6573 | Felodipine | Felodipine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 51079-467 | Felodipine | Felodipine | Mylan Institutional Inc. | ANDA | Current |