Application 076421
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLECAINIDE ACETATE | FLECAINIDE ACETATE | TABLET;ORAL | 50MG | No | No |
| 002 | FLECAINIDE ACETATE | FLECAINIDE ACETATE | TABLET;ORAL | 100MG | No | No |
| 003 | FLECAINIDE ACETATE | FLECAINIDE ACETATE | TABLET;ORAL | 150MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63304-794 | Flecainide Acetate | Flecainide | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-795 | Flecainide Acetate | Flecainide | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-796 | Flecainide Acetate | Flecainide | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |