Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021988
Company: STRIDES ACROLAB
Company: STRIDES ACROLAB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets | LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE | 150MG; 300MG; 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 |
|---|---|---|---|---|---|---|---|
| 03/02/2007 | 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/2007/021988TAltr.pdf |