Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090602
Company: RISING
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
NIFEDIPINE | NIFEDIPINE | 90MG | 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 |
---|---|---|---|---|---|---|---|
09/13/2010 | ORIG-1 | Approval |
Label is not available on this site. |