Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212786
Company: LAURUS
Company: LAURUS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;300MG;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 |
---|---|---|---|---|---|---|---|
05/14/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
TABLET;ORAL; 600MG;300MG;300MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;300MG;300MG | TABLET;ORAL | Prescription | No | AB | 212786 | LAURUS |
SYMFI | EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG;300MG;300MG | TABLET;ORAL | Prescription | Yes | AB | 022142 | MYLAN LABS LTD |