Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208521
Company: MAIA PHARMS INC
Company: MAIA PHARMS INC
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% (5GM/50ML;5GM/50ML) | 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 |
---|---|---|---|---|---|---|---|
05/08/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208521Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/04/2023 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
SODIUM PHENYLACETATE AND SODIUM BENZOATE
SOLUTION;INTRAVENOUS; 10%;10% (5GM/50ML;5GM/50ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMMONUL | SODIUM BENZOATE; SODIUM PHENYLACETATE | 10%;10% (5GM/50ML;5GM/50ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 020645 | BAUSCH |
SODIUM PHENYLACETATE AND SODIUM BENZOATE | SODIUM BENZOATE; SODIUM PHENYLACETATE | 10%;10% (5GM/50ML;5GM/50ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207096 | AILEX PHARMS LLC |
SODIUM PHENYLACETATE AND SODIUM BENZOATE | SODIUM BENZOATE; SODIUM PHENYLACETATE | 10%;10% (5GM/50ML;5GM/50ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 208521 | MAIA PHARMS INC |
SODIUM PHENYLACETATE AND SODIUM BENZOATE | SODIUM BENZOATE; SODIUM PHENYLACETATE | 10%;10% (5GM/50ML;5GM/50ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 205880 | NAVINTA LLC |