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FDA ANDA · ANDA074567
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
Sponsor: OHM LABS
APPLICATION
ANDA074567
TYPE
ANDA
ORIGINAL APPROVAL
2001-04-17
LATEST ACTION
2012-01-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
IBUPROHM COLD AND SINUSOver-the-counter
IBUPROFEN 200MG, PSEUDOEPHEDRINE HYDROCHLORIDE 30MG · TABLET · ORAL
Approval history
2012-01-09Labeling · Supplement 28AP
2012-01-09Labeling · Supplement 29AP
2012-01-09Labeling · Supplement 27AP
2008-08-18Labeling · Supplement 26AP
2006-09-27Labeling · Supplement 23AP
2006-03-22Labeling · Supplement 20AP
2004-07-19Labeling · Supplement 17AP
2002-08-13Labeling · Supplement 9AP
2002-07-17Labeling · Supplement 8AP
2002-07-17Manufacturing (CMC) · Supplement 6AP
2002-07-17Manufacturing (CMC) · Supplement 7AP
2002-05-17Manufacturing (CMC) · Supplement 4AP
2002-05-17Manufacturing (CMC) · Supplement 5AP
2002-01-31Manufacturing (CMC) · Supplement 3AP
2002-01-28Manufacturing (CMC) · Supplement 1AP
2001-08-29Labeling · Supplement 2AP
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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