Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022085
Company: MATRIX LABS
Company: MATRIX LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAMIVUDINE; STAVUDINE | LAMIVUDINE; STAVUDINE | 150MG; 30MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| LAMIVUDINE; STAVUDINE | LAMIVUDINE; STAVUDINE | 150MG; 40MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/02/2007 | 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/2007/022085TAltr.pdf |