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FDA ANDA · ANDA205880

SODIUM PHENYLACETATE AND SODIUM BENZOATE

Sponsor: NAVINTA LLC

APPLICATION
ANDA205880
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-04
LATEST ACTION
2023-09-29
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

2023-09-29Labeling · Supplement 1 · standardAP
2016-08-04UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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