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FDA NDA · NDA020547

ZAFIRLUKAST

Sponsor: STRIDES PHARMA INTL

APPLICATION
NDA020547
TYPE
NDA
ORIGINAL APPROVAL
1996-09-26
LATEST ACTION
2016-03-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ACCOLATE · ReferencePrescription
ZAFIRLUKAST 10MG · TABLET · ORAL
ACCOLATE · ReferencePrescription
ZAFIRLUKAST 20MG · TABLET · ORAL

Approval history

2016-03-29Manufacturing (CMC) · Supplement 34 · standardAP
2013-11-15Labeling · Supplement 33 · standard — Letter ↗AP
2013-05-15Manufacturing (CMC) · Supplement 32 · standardAP
2011-08-08Labeling · Supplement 31 · unknown — Label ↗AP
2010-10-13Labeling · Supplement 30 · unknown — Letter ↗AP
2010-07-14Labeling · Supplement 29 · unknown — Label ↗AP
2009-08-21Labeling · Supplement 27 · standard — Label ↗AP
2008-05-29Labeling · Supplement 25 · standard — Letter ↗AP
2005-06-06Labeling · Supplement 22 · standard — Letter ↗AP
2004-03-26Labeling · Supplement 19 · standard — Label ↗AP
2003-10-31Labeling · Supplement 17 · standard — Letter ↗AP
2001-04-27Efficacy · Supplement 14 · standard — Letter ↗AP
2001-01-08Manufacturing (CMC) · Supplement 16 · standardAP
2000-09-19Manufacturing (CMC) · Supplement 15 · standardAP
2000-06-12Labeling · Supplement 13 · standardAP
2000-02-07Labeling · Supplement 11 · standard — Review ↗AP
1999-11-12Manufacturing (CMC) · Supplement 12 · standardAP
1999-09-17Efficacy · Supplement 7 · standard — Review ↗AP
1999-09-09Manufacturing (CMC) · Supplement 10 · standardAP
1999-04-30Manufacturing (CMC) · Supplement 9 · standardAP
1999-03-17Labeling · Supplement 8 · standard — Review ↗AP
1998-08-17Labeling · Supplement 6 · standardAP
1998-05-06Manufacturing (CMC) · Supplement 5 · standardAP
1998-05-06Manufacturing (CMC) · Supplement 3 · standardAP
1998-01-23Labeling · Supplement 4 · standardAP
1997-07-10Labeling · Supplement 2 · standardAP
1997-04-28Labeling · Supplement 1 · standardAP
1996-09-26Type 1 - New Molecular Entity · Original · standard — Review ↗AP
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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