Application 090636
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-820 | Tenofovir Disoproxil Fumarate | Tenofovir Disoproxil Fumarate | NorthStar RxLLC | ANDA | Current |
| 31722-535 | Tenofovir Disoproxil Fumarate | Tenofovir Disoproxil Fumarate | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 42291-800 | Tenofovir Disoproxil Fumarate | Tenofovir Disoproxil Fumarate | AvKARE, Inc. | ANDA | Current |
| 42291-800 | Tenofovir Disoproxil Fumarate | Tenofovir Disoproxil Fumarate | AvKARE | ANDA | Current |
| 42291-800 | Tenofovir Disoproxil Fumarate | Tenofovir Disoproxil Fumarate | AvKARE | ANDA | Current |
| 70518-2151 | Tenofovir Disoproxil Fumarate | Tenofovir Disoproxil Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2151 | Tenofovir Disoproxil Fumarate | Tenofovir Disoproxil Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2151 | Tenofovir Disoproxil Fumarate | Tenofovir Disoproxil Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2151 | Tenofovir Disoproxil Fumarate | Tenofovir Disoproxil Fumarate | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9282 | ORIG | 2010-04-05 |