Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201802
Company: STRIDES PHARMA
Company: STRIDES PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;200MG;300MG | TABLET;ORAL | Discontinued | None | No | No |
EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET;ORAL | Prescription | AB | No | No |
EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG | 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 |
---|---|---|---|---|---|---|---|
10/03/2023 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
TABLET;ORAL; 300MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET;ORAL | Prescription | No | AB | 201802 | STRIDES PHARMA |
TABLET;ORAL; 600MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG | TABLET;ORAL | Prescription | No | AB | 201802 | STRIDES PHARMA |