Application 202821
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| 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 | Labeler | Marketing category | Status |
|---|
| 50090-2233 | Flecainide Acetate | Flecainide Acetate | A-S Medication Solutions | ANDA | Current |
| 50090-5267 | Flecainide Acetate | Flecainide Acetate | A-S Medication Solutions | ANDA | Current |
| 50090-5267 | Flecainide Acetate | Flecainide Acetate | A-S Medication Solutions | ANDA | Current |
| 50090-5306 | Flecainide Acetate | Flecainide Acetate | A-S Medication Solutions | ANDA | Current |
| 50090-5306 | Flecainide Acetate | Flecainide Acetate | A-S Medication Solutions | ANDA | Current |
| 57237-063 | Flecainide Acetate | Flecainide Acetate | Rising Health, LLC | ANDA | Current |
| 57237-063 | Flecainide Acetate | Flecainide Acetate | Rising Health, LLC | ANDA | Current |
| 57237-063 | Flecainide Acetate | Flecainide Acetate | Rising Health, LLC | ANDA | Current |
| 57237-064 | Flecainide Acetate | Flecainide Acetate | Rising Health, LLC | ANDA | Current |
| 57237-064 | Flecainide Acetate | Flecainide Acetate | Rising Health, LLC | ANDA | Current |
| 57237-064 | Flecainide Acetate | Flecainide Acetate | Rising Health, LLC | ANDA | Current |
| 57237-065 | Flecainide Acetate | Flecainide Acetate | Rising Health, LLC | ANDA | Current |
| 57237-065 | Flecainide Acetate | Flecainide Acetate | Rising Health, LLC | ANDA | Current |
| 57237-065 | Flecainide Acetate | Flecainide Acetate | Rising Health, LLC | ANDA | Current |
| 63629-7979 | Flecainide Acetate | Flecainide Acetate | Bryant Ranch Prepack | ANDA | Current |
| 63629-7979 | Flecainide Acetate | Flecainide Acetate | Bryant Ranch Prepack | ANDA | Current |
| 63629-7979 | Flecainide Acetate | Flecainide Acetate | Bryant Ranch Prepack | ANDA | Current |
| 63629-7982 | Flecainide Acetate | Flecainide Acetate | Bryant Ranch Prepack | ANDA | Current |
| 63629-7982 | Flecainide Acetate | Flecainide Acetate | Bryant Ranch Prepack | ANDA | Current |
| 65862-621 | Flecainide Acetate | Flecainide Acetate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-621 | Flecainide Acetate | Flecainide Acetate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-621 | Flecainide Acetate | Flecainide Acetate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-622 | Flecainide Acetate | Flecainide Acetate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-622 | Flecainide Acetate | Flecainide Acetate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-622 | Flecainide Acetate | Flecainide Acetate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-623 | Flecainide Acetate | Flecainide Acetate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-623 | Flecainide Acetate | Flecainide Acetate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-623 | Flecainide Acetate | Flecainide Acetate | Aurobindo Pharma Limited | ANDA | Current |
| 71335-2172 | Flecainide Acetate | Flecainide Acetate | Bryant Ranch Prepack | ANDA | Current |