FDA NDA · NDA021281

PREVACID

Sponsor: TAKEDA PHARMS NA

APPLICATION

NDA021281

TYPE

NDA

ORIGINAL APPROVAL

2001-05-03

LATEST ACTION

2009-07-31

ROUTE

ORAL

DOSAGE FORM

FOR SUSPENSION, DELAYED RELEASE

MARKETING STATUS

Discontinued

Products

PREVACIDDiscontinued

LANSOPRAZOLE 30MG/PACKET · FOR SUSPENSION, DELAYED RELEASE · ORAL

PREVACIDDiscontinued

LANSOPRAZOLE 15MG/PACKET · FOR SUSPENSION, DELAYED RELEASE · ORAL

2009-07-31Supplement · Supplement 26 · standard — Label ↗AP

2008-10-28Labeling · Supplement 24 · standard — Label ↗AP

2008-04-21Labeling · Supplement 22 · standard — Letter ↗AP

2007-06-14Labeling · Supplement 21 · standard — Letter ↗AP

2006-04-12Labeling · Supplement 17 · standard — Label ↗AP

2004-06-17Efficacy · Supplement 14 · standard — Label ↗AP

2004-06-15Labeling · Supplement 13 · standardAP

2003-08-05Labeling · Supplement 9 · standard — Letter ↗AP

2002-12-03Labeling · Supplement 4 · standard — Letter ↗AP

2002-12-03Manufacturing (CMC) · Supplement 5 · standardAP

2002-08-30Labeling · Supplement 7 · standard — Review ↗AP

2002-05-03Labeling · Supplement 2 · standard — Label ↗AP

2002-03-07Manufacturing (CMC) · Supplement 3 · standardAP

2001-12-07Manufacturing (CMC) · Supplement 1 · standardAP

2001-05-03Type 3 - New Dosage Form · Original · standard — Review ↗AP

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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