← FDA DRUG APPROVALS

FDA NDA · NDA021744

PROQUIN XR

Sponsor: DEPOMED INC

APPLICATION
NDA021744
TYPE
NDA
ORIGINAL APPROVAL
2005-05-19
LATEST ACTION
2011-08-15
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

PROQUIN XRDiscontinued
CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2011-08-15Labeling · Supplement 19 · standardAP
2011-02-25Labeling · Supplement 16 · standard — Letter ↗AP
2010-12-29Labeling · Supplement 14 · standard — Letter ↗AP
2009-05-07Labeling · Supplement 13 · standard — Letter ↗AP
2009-04-27Labeling · Supplement 12 · standard — Label ↗AP
2008-10-17Supplement · Supplement 10 · standard — Letter ↗AP
2008-10-17Supplement · Supplement 7 · standard — Letter ↗AP
2008-10-03Labeling · Supplement 8 · standard — Label ↗AP
2007-09-04Labeling · Supplement 5 · standard — Label ↗AP
2007-08-10Labeling · Supplement 4 · standard — Label ↗AP
2007-08-01Labeling · Supplement 3 · standard — Letter ↗AP
2006-08-17Manufacturing (CMC) · Supplement 2 · standard — Label ↗AP
2005-05-19Type 2 - New Active Ingredient · Original · standard — Label ↗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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