Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204320
Company: AJANTA PHARMA LTD
Company: AJANTA PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OLANZAPINE | OLANZAPINE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
OLANZAPINE | OLANZAPINE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
OLANZAPINE | OLANZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
OLANZAPINE | OLANZAPINE | 20MG | TABLET, ORALLY DISINTEGRATING;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 |
---|---|---|---|---|---|---|---|
05/30/2017 | ORIG-1 | Approval |
Label is not available on this site. |