Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075414
Company: MARTEC USA LLC
Company: MARTEC USA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE; ORAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
03/23/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/075414s000_ltr.pdf |