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FDA ANDA · ANDA075153
LEADER 12 HOUR SINUS NASAL DECONGESTANT
pseudoephedrine hcl
Sponsor: L PERRIGO CO
APPLICATION
ANDA075153
TYPE
ANDA
ORIGINAL APPROVAL
1999-02-26
LATEST ACTION
2011-05-24
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter
Products
PSEUDOEPHEDRINE HYDROCHLORIDEOver-the-counter
PSEUDOEPHEDRINE HYDROCHLORIDE 120MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2011-05-24Labeling · Supplement 34AP
2005-04-20Labeling · Supplement 17AP
2002-12-09Manufacturing (CMC) · Supplement 9AP
2002-05-07Manufacturing (CMC) · Supplement 5AP
2002-05-07Manufacturing (CMC) · Supplement 6AP
2001-12-12Labeling · Supplement 8AP
2001-10-22Manufacturing (CMC) · Supplement 7AP
2001-04-17Manufacturing (CMC) · Supplement 3AP
2001-04-17Manufacturing (CMC) · Supplement 4AP
2000-02-28Manufacturing (CMC) · Supplement 1AP
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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