Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214053
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | 120MG;EQ 15MG BASE | TABLET;ORAL | Prescription | AB | No | No |
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | 200MG;EQ 25MG BASE | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/17/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE
TABLET;ORAL; 120MG;EQ 15MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DESCOVY | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | 120MG;EQ 15MG BASE | TABLET;ORAL | Prescription | Yes | AB | 208215 | GILEAD SCIENCES INC |
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | 120MG;EQ 15MG BASE | TABLET;ORAL | Prescription | No | AB | 214053 | APOTEX |
TABLET;ORAL; 200MG;EQ 25MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DESCOVY | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | 200MG;EQ 25MG BASE | TABLET;ORAL | Prescription | Yes | AB | 208215 | GILEAD SCIENCES INC |
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE | EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | 200MG;EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 214053 | APOTEX |