Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203076
Company: CIPLA LTD
Company: CIPLA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE | LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE | 30MG; 50MG; 60MG | TABLET; ORAL SUSPENSION | 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 |
|---|---|---|---|---|---|---|---|
| 10/16/2012 | ORIG-1 | Tentative Approval | Type 3 - New Dosage Form and Type 4 - New Combination | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203076Orig1s000ltr.pdf |