Application 202123
- Type
- NDA
- Sponsor
- GILEAD SCIENCES INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | COMPLERA | EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE | TABLET;ORAL | 200MG;EQ 25MG BASE;300MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-1248 | COMPLERA | emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate | A-S Medication Solutions | NDA | Current |
| 61958-1101 | COMPLERA | emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate | Gilead Sciences, Inc. | NDA | Current |
| 61958-1101 | COMPLERA | emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate | Gilead Sciences, Inc. | NDA | Current |
| 61958-1101 | COMPLERA | emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate | Gilead Sciences, Inc. | NDA | Current |
| 61958-1101 | COMPLERA | emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate | Gilead Sciences, Inc. | NDA | Current |
| 70518-0677 | COMPLERA | emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate | REMEDYREPACK INC. | NDA | Current |
| 70518-0677 | COMPLERA | emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate | REMEDYREPACK INC. | NDA | Current |
| 70518-0677 | COMPLERA | emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate | REMEDYREPACK INC. | NDA | Current |