Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207745
Company: SIGMAPHARM LABS LLC
Company: SIGMAPHARM LABS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NITROGLYCERIN | NITROGLYCERIN | 0.3MG | TABLET;SUBLINGUAL | Discontinued | None | No | No |
NITROGLYCERIN | NITROGLYCERIN | 0.4MG | TABLET;SUBLINGUAL | Discontinued | None | No | No |
NITROGLYCERIN | NITROGLYCERIN | 0.6MG | TABLET;SUBLINGUAL | 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 |
---|---|---|---|---|---|---|---|
05/07/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |