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FDA ANDA · ANDA076478

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Sponsor: PERRIGO

APPLICATION
ANDA076478
TYPE
ANDA
ORIGINAL APPROVAL
2003-11-05
LATEST ACTION
2012-03-30
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEDiscontinued
IBUPROFEN 100MG/5ML, PSEUDOEPHEDRINE HYDROCHLORIDE 15MG/5ML · SUSPENSION · ORAL

Approval history

2012-03-30Labeling · Supplement 23AP
2012-03-30Labeling · Supplement 30AP
2006-03-22Labeling · Supplement 15AP
2003-11-05OriginalAP
VIEW ON DRUGS@FDA ↗

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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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