Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205493
Company: MICRO LABS LTD
Company: MICRO LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE | LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE | 300MG;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 |
---|---|---|---|---|---|---|---|
01/25/2018 | 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/2018/205493Orig1s000TAltr.pdf |