Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075943
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ETODOLAC | ETODOLAC | 400MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
ETODOLAC | ETODOLAC | 500MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
ETODOLAC | ETODOLAC | 600MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
07/26/2002 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/22/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |