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FDA ANDA · ANDA075588

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Sponsor: CONTRACT PHARMACAL

APPLICATION
ANDA075588
TYPE
ANDA
ORIGINAL APPROVAL
2002-04-08
LATEST ACTION
2006-03-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEDiscontinued
IBUPROFEN 200MG, PSEUDOEPHEDRINE HYDROCHLORIDE 30MG · TABLET · ORAL

Approval history

2006-03-22Labeling · Supplement 2AP
2002-10-09Manufacturing (CMC) · Supplement 1AP
2002-04-08OriginalLabelAP
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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