← FDA DRUG APPROVALS

FDA NDA · NDA021799

QUALAQUIN

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
NDA021799
TYPE
NDA
ORIGINAL APPROVAL
2005-08-12
LATEST ACTION
2019-06-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

QUALAQUIN · ReferenceDiscontinued
QUININE SULFATE 324MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2019-06-19Labeling · Supplement 29 · standard — Label ↗AP
2014-07-02Labeling · Supplement 24 · standard — Label ↗AP
2013-04-13Labeling · Supplement 23 · standard — Label ↗AP
2013-02-22Labeling · Supplement 21 · standard — Label ↗AP
2012-05-22REMS · Supplement 20AP
2012-05-22Labeling · Supplement 22 · standard — Letter ↗AP
2011-04-14Labeling · Supplement 16 · standard — Label ↗AP
2010-06-15Labeling · Supplement 11 · standard — Letter ↗AP
2010-01-22Labeling · Supplement 15 · unknown — Letter ↗AP
2009-12-23Labeling · Supplement 13 · standard — Letter ↗AP
2009-11-20Labeling · Supplement 14 · unknown — Label ↗AP
2008-11-14Labeling · Supplement 8 · standard — Letter ↗AP
2007-10-03Labeling · Supplement 6 · standard — Letter ↗AP
2005-08-12Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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