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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 four 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. Eight suppliers are listed for this compound. Additional details are available on the chlorpheniramine polistirex; hydrocodone polistirex profile page.

Summary for NDA: 091632

Pharmacology for NDA: 091632

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 Atlantic Biologicals Corps 17856-0235 17856-0235-1 5 mL in 1 CUP, UNIT-DOSE (17856-0235-1)
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
chlorpheniramine polistirex; hydrocodone polistirex
SUSPENSION, EXTENDED RELEASE;ORAL 091632 ANDA Tris Pharma Inc 27808-086 27808-086-01 1 BOTTLE, UNIT-DOSE in 1 CARTON (27808-086-01) > 115 mL in 1 BOTTLE, UNIT-DOSE

Summary 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:ABRLD:No


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