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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 091632


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NDA 091632 describes HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX, which is a drug marketed by Tris Pharma Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX profile page.

The generic ingredient in HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX 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 091632
Tradename:HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
Applicant:Tris Pharma Inc
Ingredient:chlorpheniramine polistirex; hydrocodone polistirex
Patents:0
Pharmacology for NDA: 091632
Mechanism of ActionHistamine H1 Receptor Antagonists
Opioid Agonists
Suppliers and Packaging for NDA: 091632
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX chlorpheniramine polistirex; hydrocodone polistirex SUSPENSION, EXTENDED RELEASE;ORAL 091632 ANDA Cranbury Pharmaceuticals, LLC 27808-086 27808-086-01 1 BOTTLE, UNIT-DOSE in 1 CARTON (27808-086-01) / 115 mL in 1 BOTTLE, UNIT-DOSE
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX chlorpheniramine polistirex; hydrocodone polistirex SUSPENSION, EXTENDED RELEASE;ORAL 091632 ANDA Cranbury Pharmaceuticals, LLC 27808-086 27808-086-02 473 mL in 1 BOTTLE (27808-086-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;ORALStrengthEQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML
Approval Date:Oct 1, 2010TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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