Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217526
Company: NAVINTA LLC
Company: NAVINTA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM PHENYLACETATE AND SODIUM BENZOATE | SODIUM BENZOATE; SODIUM PHENYLACETATE | 10%;10% (2GM/20ML; 2GM/20ML) | SOLUTION;INTRAVENOUS | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
07/14/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
SODIUM PHENYLACETATE AND SODIUM BENZOATE
SOLUTION;INTRAVENOUS; 10%;10% (2GM/20ML; 2GM/20ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SODIUM PHENYLACETATE AND SODIUM BENZOATE | SODIUM BENZOATE; SODIUM PHENYLACETATE | 10%;10% (2GM/20ML; 2GM/20ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217526 | NAVINTA LLC |