Application 073262
- Type
- ANDA
- Sponsor
- EPIC PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SULINDAC | SULINDAC | TABLET;ORAL | 200MG | No | No |
| 002 | SULINDAC | SULINDAC | TABLET;ORAL | 150MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 23155-005 | Sulindac | Sulindac | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-006 | Sulindac | Sulindac | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 53808-0303 | Sulindac | SULINDAC | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0799 | Sulindac | SULINDAC | State of Florida DOH Central Pharmacy | ANDA | Current |