Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078053
Company: RANBAXY LABS LTD
Company: RANBAXY LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 20MG BASE/ML | CONCENTRATE;ORAL | Discontinued | 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 |
---|---|---|---|---|---|---|---|
11/30/2006 | ORIG-1 | Tentative Approval |
Label is not available on this site. |