Application 209908
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TADALAFIL | TADALAFIL | TABLET;ORAL | 2.5MG | No | No |
| 002 | TADALAFIL | TADALAFIL | TABLET;ORAL | 5MG | No | No |
| 003 | TADALAFIL | TADALAFIL | TABLET;ORAL | 10MG | No | No |
| 004 | TADALAFIL | TADALAFIL | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 31722-643 | Tadalafil | Tadalafil | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-644 | Tadalafil | Tadalafil | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-645 | Tadalafil | Tadalafil | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-646 | Tadalafil | Tadalafil | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 50090-4660 | Tadalafil | Tadalafil | A-S Medication Solutions | ANDA | Current |
| 50090-4660 | Tadalafil | Tadalafil | A-S Medication Solutions | ANDA | Current |
| 50436-0644 | Tadalafil | Tadalafil | Unit Dose Services | ANDA | Current |
| 50436-0644 | Tadalafil | Tadalafil | Unit Dose Services | ANDA | Current |
| 50436-0644 | Tadalafil | Tadalafil | Unit Dose Services | ANDA | Current |
| 50436-0645 | Tadalafil | Tadalafil | Unit Dose Services | ANDA | Current |
| 50436-0645 | Tadalafil | Tadalafil | Unit Dose Services | ANDA | Current |
| 50436-6440 | Tadalafil | Tadalafil | Unit Dose Services | ANDA | Current |
| 50436-6460 | Tadalafil | Tadalafil | Unit Dose Services | ANDA | Current |
| 61919-887 | Tadalafil | Tadalafil | Direct_Rx | ANDA | Current |
| 61919-887 | Tadalafil | Tadalafil | Direct_Rx | ANDA | Current |
| 61919-887 | Tadalafil | Tadalafil | Direct_Rx | ANDA | Current |
| 61919-889 | Tadalafil | Tadalafil | Direct_Rx | ANDA | Current |
| 68071-5092 | Tadalafil | Tadalafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5092 | Tadalafil | Tadalafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5110 | Tadalafil | Tadalafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5110 | Tadalafil | Tadalafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5116 | Tadalafil | Tadalafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5116 | Tadalafil | Tadalafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5138 | Tadalafil | Tadalafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5138 | Tadalafil | Tadalafil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 71335-1239 | Tadalafil | Tadalafil | Bryant Ranch Prepack | ANDA | Current |
| 71335-1334 | Tadalafil | Tadalafil | Bryant Ranch Prepack | ANDA | Current |
| 71610-298 | Tadalafil | Tadalafil | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |