Application 075998
- Type
- ANDA
- Sponsor
- SUN PHARM INDUSTRIES
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 |
|---|
| 50090-2949 | PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | A-S Medication Solutions | ANDA | Current |
| 53489-551 | PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53489-552 | PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53489-553 | PROPAFENONE HYDROCHLORIDE | propafenone hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 8845 | ORIG | 2003-04-10 |