Application 018830
- Type
- NDA
- Sponsor
- CNTY LINE PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TAMBOCOR | FLECAINIDE ACETATE | TABLET;ORAL | 100MG | Yes | No |
| 002 | TAMBOCOR | FLECAINIDE ACETATE | TABLET;ORAL | 200MG | No | No |
| 003 | TAMBOCOR | FLECAINIDE ACETATE | TABLET;ORAL | 150MG | Yes | No |
| 004 | TAMBOCOR | FLECAINIDE ACETATE | TABLET;ORAL | 50MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43199-056 | Flecainide acetate | Flecainide acetate | County Line Pharmaceuticals, LLC | NDA | Current |
| 43199-057 | Flecainide acetate | Flecainide acetate | County Line Pharmaceuticals, LLC | NDA | Current |
| 43199-058 | Flecainide acetate | Flecainide acetate | County Line Pharmaceuticals, LLC | NDA | Current |