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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. It is available from two suppliers. 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. Eight suppliers are listed for this compound. Additional details are available on the chlorpheniramine polistirex; hydrocodone polistirex profile page.

Summary for NDA: 019111

Tradename:
TUSSIONEX PENNKINETIC
Applicant:
Ucb Inc
Ingredient:
chlorpheniramine polistirex; hydrocodone polistirex
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 019111

Suppliers and Packaging for NDA: 019111

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TUSSIONEX PENNKINETIC
chlorpheniramine polistirex; hydrocodone polistirex
SUSPENSION, EXTENDED RELEASE;ORAL 019111 NDA Unither Manufacturing, LLC 53014-548 53014-548-01 1 BOTTLE, PLASTIC in 1 CARTON (53014-548-01) > 115 mL in 1 BOTTLE, PLASTIC
TUSSIONEX PENNKINETIC
chlorpheniramine polistirex; hydrocodone polistirex
SUSPENSION, EXTENDED RELEASE;ORAL 019111 NDA AUTHORIZED GENERIC Kremers Urban Pharmaceuticals Inc. 62175-490 62175-490-64 1 BOTTLE, GLASS in 1 CARTON (62175-490-64) > 115 mL in 1 BOTTLE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;ORALStrengthEQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML
Approval Date:Dec 31, 1987TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 019111

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc
TUSSIONEX PENNKINETIC
chlorpheniramine polistirex; hydrocodone polistirex
SUSPENSION, EXTENDED RELEASE;ORAL019111-001Dec 31, 19874,221,778► subscribe
Ucb Inc
TUSSIONEX PENNKINETIC
chlorpheniramine polistirex; hydrocodone polistirex
SUSPENSION, EXTENDED RELEASE;ORAL019111-001Dec 31, 19874,762,709► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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