← FDA DRUG APPROVALS

FDA ANDA · ANDA203335

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA203335
TYPE
ANDA
ORIGINAL APPROVAL
2015-10-30
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 5AP
2015-10-30UNKNOWN · Original — REMS ↗AP
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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