Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091168
Company: CIPLA
Company: CIPLA
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 |
---|---|---|---|---|---|---|---|
07/02/2018 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091168s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/091168Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/22/2020 | SUPPL-7 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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 |