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Last Updated: June 20, 2021

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Chlorpheniramine polistirex; hydrocodone polistirex - Generic Drug Details

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What are the generic sources for chlorpheniramine polistirex; hydrocodone polistirex and what is the scope of freedom to operate?

Chlorpheniramine polistirex; hydrocodone polistirex is the generic ingredient in four branded drugs marketed by Ecr Pharma, Tris Pharma Inc, Neos Therap Inc, and Ucb Inc, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for chlorpheniramine polistirex; hydrocodone polistirex. Five suppliers are listed for this compound.

Summary for chlorpheniramine polistirex; hydrocodone polistirex
Recent Clinical Trials for chlorpheniramine polistirex; hydrocodone polistirex

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
MallinckrodtPhase 1

See all chlorpheniramine polistirex; hydrocodone polistirex clinical trials

Pharmacology for chlorpheniramine polistirex; hydrocodone polistirex
Paragraph IV (Patent) Challenges for CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX
Tradename Dosage Ingredient NDA Submissiondate
TUSSIONEX PENNKINETIC SUSPENSION, EXTENDED RELEASE;ORAL chlorpheniramine polistirex; hydrocodone polistirex 019111 2004-09-10

US Patents and Regulatory Information for chlorpheniramine polistirex; hydrocodone polistirex

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ucb Inc TUSSIONEX PENNKINETIC chlorpheniramine polistirex; hydrocodone polistirex SUSPENSION, EXTENDED RELEASE;ORAL 019111-001 Dec 31, 1987 DISCN Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Neos Therap Inc HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX chlorpheniramine polistirex; hydrocodone polistirex SUSPENSION, EXTENDED RELEASE;ORAL 091671-001 Jun 29, 2012 AB RX No Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Tris Pharma Inc HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX chlorpheniramine polistirex; hydrocodone polistirex SUSPENSION, EXTENDED RELEASE;ORAL 091632-001 Oct 1, 2010 AB RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Ecr Pharma TUSSICAPS chlorpheniramine polistirex; hydrocodone polistirex CAPSULE, EXTENDED RELEASE;ORAL 077273-001 Sep 24, 2007 RX No Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Ecr Pharma TUSSICAPS chlorpheniramine polistirex; hydrocodone polistirex CAPSULE, EXTENDED RELEASE;ORAL 077273-002 Sep 24, 2007 RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for chlorpheniramine polistirex; hydrocodone polistirex

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   Try Before You Buy   Try Before You Buy
Ucb Inc TUSSIONEX PENNKINETIC chlorpheniramine polistirex; hydrocodone polistirex SUSPENSION, EXTENDED RELEASE;ORAL 019111-001 Dec 31, 1987   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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