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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 019111

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NDA 019111 describes TUSSIONEX PENNKINETIC, which is a drug marketed by Ucb Inc and is included in one NDA. Additional details are available on the TUSSIONEX PENNKINETIC profile page.

The generic ingredient in TUSSIONEX PENNKINETIC is chlorpheniramine polistirex; hydrocodone polistirex. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorpheniramine polistirex; hydrocodone polistirex profile page.

Summary for 019111

Tradename:	TUSSIONEX PENNKINETIC
Applicant:	Ucb Inc
Ingredient:	chlorpheniramine polistirex; hydrocodone polistirex
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION, EXTENDED RELEASE;ORAL			Strength	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 31, 1987	TE:		RLD:	Yes

Expired US Patents for NDA 019111

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	TUSSIONEX PENNKINETIC	chlorpheniramine polistirex; hydrocodone polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	019111-001	Dec 31, 1987	4,762,709	⤷ Start Trial
Ucb Inc	TUSSIONEX PENNKINETIC	chlorpheniramine polistirex; hydrocodone polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	019111-001	Dec 31, 1987	4,221,778	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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