Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022295
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ABACAVIR SULFATE; LAMIVUDINE | ABACAVIR SULFATE; LAMIVUDINE | 60MG; 30MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/19/2008 | ORIG-1 | Tentative Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022295s000ltr.pdf |