Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210558
Company: SOMERSET THERAPS LLC
Company: SOMERSET THERAPS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISOSULFAN BLUE | ISOSULFAN BLUE | 50MG/5ML (10MG/ML) | SOLUTION;SUBCUTANEOUS | 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 |
---|---|---|---|---|---|---|---|
07/12/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |