Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022464
Company: STRIDES ARCOLAB LTD
Company: STRIDES ARCOLAB LTD
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 |
---|---|---|---|---|---|---|---|
12/22/2009 | ORIG-1 | Tentative Approval | Type 4 - New Combination | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022464s000ltr.pdf |