Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075108
Company: PHARMOBEDIENT
Company: PHARMOBEDIENT
| 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/17/1999 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75108_Nifedipine_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75108ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75108ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75108_Nifedipine.html |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/17/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75108_Nifedipine_prntlbl.pdf |