Application 019111

Type: NDA
Sponsor: UCB INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TUSSIONEX PENNKINETIC	CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX	SUSPENSION, EXTENDED RELEASE;ORAL	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019111-001	TUSSIONEX PENNKINETIC	CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL		RLD	1987-12-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50474-150	Tussionex Pennkinetic	hydrocodone and chlorpheniramine	UCB Inc.	NDA	Current
53014-548	Tussionex Pennkinetic	hydrocodone polistirex and chlorpheniramine polistirex	Unither Manufacturing LLC	NDA	Current
62175-490	Hydrocodone Polistirex and Chlorpheniramine Polistirex Pennkinetic	hydrocodone polistirex and chlorpheniramine polistirex	Kremers Urban Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54848	SUPPL	2018-07-06
54789	SUPPL	2018-07-06
54752	SUPPL	2018-07-05
46887	SUPPL	2017-01-24
46870	SUPPL	2017-01-13
16197	SUPPL	2015-04-03
33698	SUPPL	2015-04-02
16196	SUPPL	2011-06-09
20206	SUPPL	2008-08-01
44029	ORIG	2008-03-13
16195	SUPPL	2008-03-13
11436	SUPPL	2008-03-13
1228	SUPPL	2003-11-25