Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091593
Company: CIPLA LIMITED
Company: CIPLA LIMITED
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 600MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 200MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET; ORAL | None (Tentative Approval) | None | 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 |
|---|---|---|---|---|---|---|---|
| 02/27/2012 | ORIG-1 | Tentative Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091593s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/05/2017 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |