Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 200793
Company: MATRIX LABS
Company: MATRIX LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAMIVUDINE/NEVIRAPINE/ZIDOVUDINE TABLETS | Lamivudine; Nevirapine; Zidovudine | 30MG; 50MG; 60MG | TABLET, FOR SUSPENSION; 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 |
|---|---|---|---|---|---|---|---|
| 07/08/2010 | ORIG-1 | Tentative Approval | Type 3 - New Dosage Form and Type 4 - New Combination | PRIORITY |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200793s000ltr.pdf |