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FDA ANDA · ANDA077628

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Sponsor: STRIDES PHARMA

APPLICATION
ANDA077628
TYPE
ANDA
ORIGINAL APPROVAL
2006-08-14
LATEST ACTION
2015-02-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEOver-the-counter
IBUPROFEN 200MG, PSEUDOEPHEDRINE HYDROCHLORIDE 30MG · TABLET · ORAL

Approval history

2015-02-04Labeling · Supplement 7AP
2009-09-04Labeling · Supplement 4AP
2006-08-14OriginalAP
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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