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FDA ANDA · ANDA206661

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Sponsor: SCIEGEN PHARMS

APPLICATION
ANDA206661
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-23
LATEST ACTION
2023-12-15
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDEDiscontinued
HYDROCODONE BITARTRATE 5MG/5ML, PSEUDOEPHEDRINE HYDROCHLORIDE 60MG/5ML · SOLUTION · ORAL

Approval history

2023-12-15Labeling · Supplement 4 · standardAP
2019-01-23UNKNOWN · Original · standardAP
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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