Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075543
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METOLAZONE | METOLAZONE | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
METOLAZONE | METOLAZONE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
METOLAZONE | METOLAZONE | 10MG | TABLET;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 |
---|---|---|---|---|---|---|---|
12/24/2003 | ORIG-1 | Approval |
Label is not available on this site. |