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FDA ANDA · ANDA208521
SODIUM PHENYLACETATE AND SODIUM BENZOATE
Sponsor: MAIA PHARMS INC
APPLICATION
ANDA208521
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-08
LATEST ACTION
2023-05-04
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
SODIUM PHENYLACETATE AND SODIUM BENZOATEPrescription
SODIUM BENZOATE 10%, SODIUM PHENYLACETATE 10% (5GM/50ML · SOLUTION · INTRAVENOUS
Approval history
2023-05-04Labeling · Supplement 2 · standardAP
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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