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FDA ANDA · ANDA080857

DIPHENYLAN SODIUM

Sponsor: CHARTWELL MOLECULAR

APPLICATION
ANDA080857
TYPE
ANDA
ORIGINAL APPROVAL
1976-12-03
LATEST ACTION
1985-09-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

DIPHENYLAN SODIUMDiscontinued
PHENYTOIN SODIUM 100MG PROMPT · CAPSULE · ORAL
DIPHENYLAN SODIUMDiscontinued
PHENYTOIN SODIUM 30MG PROMPT · CAPSULE · ORAL

Approval history

1985-09-09Manufacturing (CMC) · Supplement 14AP
1976-12-03OriginalAP
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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