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Details for New Drug Application (NDA): 091671

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NDA 091671 describes HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX, which is a drug marketed by Neos Therap Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX profile page.

The generic ingredient in HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE 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: 091671

Pharmacology for NDA: 091671

Suppliers and Packaging for NDA: 091671

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX
chlorpheniramine polistirex; hydrocodone polistirex
SUSPENSION, EXTENDED RELEASE;ORAL 091671 ANDA Atlantic Biologicals Corps 17856-0301 17856-0301-1 72 CUP in 1 CASE (17856-0301-1) > 5 mL in 1 CUP
HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX
chlorpheniramine polistirex; hydrocodone polistirex
SUSPENSION, EXTENDED RELEASE;ORAL 091671 ANDA Neos Therapeutics, LP 62542-301 62542-301-04 118 mL in 1 BOTTLE, GLASS (62542-301-04)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;ORALStrengthEQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML
Approval Date:Jun 29, 2012TE:ABRLD:No


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