← FDA DRUG APPROVALS

FDA NDA · NDA019111

TUSSIONEX PENNKINETIC

Sponsor: UCB INC

APPLICATION
NDA019111
TYPE
NDA
ORIGINAL APPROVAL
1987-12-31
LATEST ACTION
2018-06-28
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

TUSSIONEX PENNKINETIC · ReferenceDiscontinued
CHLORPHENIRAMINE POLISTIREX EQ 8MG MALEATE/5ML, HYDROCODONE POLISTIREX EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUSPENSION, EXTENDED RELEASE · ORAL

Approval history

2018-06-28Labeling · Supplement 22 · standard — Label ↗AP
2017-01-13Labeling · Supplement 19 · standard — Label ↗AP
2015-04-01Labeling · Supplement 18 · standard — Letter ↗AP
2014-03-21Manufacturing (CMC) · Supplement 17 · standardAP
2011-06-02Manufacturing (CMC) · Supplement 16 · standard — Letter ↗AP
2008-03-11Labeling · Supplement 15 · standard — Label ↗AP
2003-11-12Labeling · Supplement 11 · standard — Letter ↗AP
2001-06-07Manufacturing (CMC) · Supplement 9 · standardAP
2000-11-13Manufacturing (CMC) · Supplement 8 · standardAP
2000-03-03Manufacturing (CMC) · Supplement 7 · standardAP
2000-02-29Manufacturing (CMC) · Supplement 6 · standardAP
1999-07-30Manufacturing (CMC) · Supplement 5 · standardAP
1996-12-27Manufacturing (CMC) · Supplement 4 · standardAP
1993-12-20Manufacturing (CMC) · Supplement 1 · standardAP
1993-11-26Labeling · Supplement 2AP
1993-11-26Labeling · Supplement 3AP
1987-12-31Type 4 - New Combination · Original · standard — Other Important Information from FDA ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →