Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021854
Company: STRIDES ACROLAB
Company: STRIDES ACROLAB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
STAVUDINE; LAMIVUDINE W/NEVIRAPINE | STAVUDINE; LAMIVUDINE; NEVIRAPINE | 40MG; 150MG; 200MG | 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 |
---|---|---|---|---|---|---|---|
03/13/2007 | ORIG-1 | Tentative Approval | Type 4 - New Combination | PRIORITY |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021854s000ltr.pdf |