Application 078800
- Type
- ANDA
- Sponsor
- CIPLA
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69097-533 | Tenofovir disoproxil fumarate | Tenofovir disoproxil fumarate | Cipla USA Inc. | ANDA | Current |
| 69097-533 | Tenofovir disoproxil fumarate | Tenofovir disoproxil fumarate | Cipla USA Inc. | ANDA | Current |
| 69097-533 | Tenofovir disoproxil fumarate | Tenofovir disoproxil fumarate | Cipla USA Inc. | ANDA | Current |
| 69097-533 | Tenofovir disoproxil fumarate | Tenofovir disoproxil fumarate | Cipla USA Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9187 | ORIG | 2009-05-06 |