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Generated: September 23, 2017

DrugPatentWatch Database Preview

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:
1
Applicant:
1
Ingredient:
1
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, PLASTIC in 1 CARTON (62175-490-64) > 115 mL in 1 BOTTLE, PLASTIC

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, 1987► Subscribe► Subscribe
Ucb Inc
TUSSIONEX PENNKINETIC
chlorpheniramine polistirex; hydrocodone polistirex
SUSPENSION, EXTENDED RELEASE;ORAL019111-001Dec 31, 1987► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Teva
US Army
Cerilliant
Moodys
UBS
Johnson and Johnson
Covington
Merck
McKinsey
Boehringer Ingelheim

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