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FDA ANDA · ANDA085381

BUTICAPS

Sponsor: MEDPOINTE PHARM HLC

APPLICATION
ANDA085381
TYPE
ANDA
ORIGINAL APPROVAL
1978-04-11
LATEST ACTION
1978-04-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

BUTICAPSDiscontinued
BUTABARBITAL SODIUM 30MG · CAPSULE · ORAL
BUTICAPSDiscontinued
BUTABARBITAL SODIUM 50MG · CAPSULE · ORAL
BUTICAPSDiscontinued
BUTABARBITAL SODIUM 15MG · CAPSULE · ORAL
BUTICAPSDiscontinued
BUTABARBITAL SODIUM 100MG · CAPSULE · ORAL

Approval history

1978-04-11OriginalAP
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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