Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091215
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
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 | 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 |
---|---|---|---|---|---|---|---|
11/09/2018 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/09/2024 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
TABLET;ORAL; 600MG;200MG;300MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATRIPLA | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;200MG;300MG | TABLET;ORAL | Prescription | Yes | AB | 021937 | GILEAD SCIENCES |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;200MG;300MG | TABLET;ORAL | Prescription | No | AB | 203041 | AUROBINDO PHARMA |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;200MG;300MG | TABLET;ORAL | Prescription | No | AB | 206894 | CIPLA |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;200MG;300MG | TABLET;ORAL | Prescription | No | AB | 203053 | HETERO LABS LTD V |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;200MG;300MG | TABLET;ORAL | Prescription | No | AB | 213541 | LAURUS |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;200MG;300MG | TABLET;ORAL | Prescription | No | AB | 204287 | MACLEODS PHARMS LTD |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;200MG;300MG | TABLET;ORAL | Prescription | No | AB | 091215 | TEVA PHARMS USA |