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FDA ANDA · ANDA074359

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

Sponsor: WATSON LABS

APPLICATION
ANDA074359
TYPE
ANDA
ORIGINAL APPROVAL
1995-08-31
LATEST ACTION
2018-09-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEDiscontinued
ASPIRIN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG, CODEINE PHOSPHATE 30MG · CAPSULE · ORAL

Approval history

2018-09-18REMS · Supplement 14AP
2002-08-29Labeling · Supplement 6AP
2002-07-31Manufacturing (CMC) · Supplement 5AP
2001-09-05Manufacturing (CMC) · Supplement 3AP
1998-10-29Manufacturing (CMC) · Supplement 2AP
1996-11-27Manufacturing (CMC) · Supplement 1AP
1995-08-31OriginalAP
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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