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FDA NDA · NDA215025

SODIUM PHENYLACETATE AND SODIUM BENZOATE

Sponsor: MAIA PHARMS INC

APPLICATION
NDA215025
TYPE
NDA
ORIGINAL APPROVAL
2021-06-10
LATEST ACTION
2021-06-10
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

SODIUM PHENYLACETATE AND SODIUM BENZOATE · ReferencePrescription
SODIUM BENZOATE 10%, SODIUM PHENYLACETATE 10% (2GM/20ML · SOLUTION · INTRAVENOUS

Approval history

2021-06-10Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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