Application 202445
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | TABLET;ORAL | 150MG | No | No |
| 002 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | TABLET;ORAL | 225MG | No | No |
| 003 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | TABLET;ORAL | 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59651-256 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-256 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-256 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-257 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-257 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-257 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-258 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-258 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-258 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |