Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202157
Company: HETERO LABS UNIT III
Company: HETERO LABS UNIT III
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE | LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE | 150MG; 200MG; 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 |
|---|---|---|---|---|---|---|---|
| 11/18/2011 | ORIG-1 | Tentative Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202157s000ltr.pdf |