Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079188
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EMTRICITABINE | EMTRICITABINE | 200MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
03/15/2023 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/079188s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/079188Orig1s000TAltr.pdf |
EMTRICITABINE
CAPSULE;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EMTRICITABINE | EMTRICITABINE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 079188 | AUROBINDO PHARMA LTD |
EMTRICITABINE | EMTRICITABINE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 091168 | CIPLA |
EMTRIVA | EMTRICITABINE | 200MG | CAPSULE;ORAL | Prescription | Yes | AB | 021500 | GILEAD |