Application 203803
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 225MG | No | No |
| 002 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 325MG | No | No |
| 003 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 425MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-1258 | Propafenone Hydrochloride | propafenone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1259 | Propafenone Hydrochloride | propafenone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1261 | Propafenone Hydrochloride | propafenone | Mylan Pharmaceuticals Inc. | ANDA | Current |