Application 091055
- Type
- ANDA
- Sponsor
- STRIDES ARCOLAB LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | TABLET; ORAL | 200MG; 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42543-719 | Emtricitabine and Tenofovir Disoproxil Fumarate | EMTRICITABINE and TENOFOVIR Disoproxil Fumarate | Strides Pharma Inc. | ANDA | Current |
| 51407-112 | Emtricitabine and Tenofovir Disoproxil Fumarate | EMTRICITABINE and TENOFOVIR Disoproxil Fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-112 | Emtricitabine and Tenofovir Disoproxil Fumarate | EMTRICITABINE and TENOFOVIR Disoproxil Fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-112 | Emtricitabine and Tenofovir Disoproxil Fumarate | EMTRICITABINE and TENOFOVIR Disoproxil Fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-112 | Emtricitabine and Tenofovir Disoproxil Fumarate | EMTRICITABINE and TENOFOVIR Disoproxil Fumarate | Golden State Medical Supply, Inc. | ANDA | Current |
| 64380-719 | Emtricitabine and Tenofovir Disoproxil Fumarate | EMTRICITABINE and TENOFOVIR Disoproxil Fumarate | Strides Pharma Science Limited | ANDA | Current |
| 64380-719 | Emtricitabine and Tenofovir Disoproxil Fumarate | EMTRICITABINE and TENOFOVIR Disoproxil Fumarate | Strides Pharma Science Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9315 | ORIG | 2013-08-05 |