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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 203133


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NDA 203133 describes DEXTROMETHORPHAN POLISTIREX, which is a drug marketed by Amneal and Tris Pharma Inc and is included in two NDAs. It is available from twenty-five suppliers. Additional details are available on the DEXTROMETHORPHAN POLISTIREX profile page.

The generic ingredient in DEXTROMETHORPHAN POLISTIREX is dextromethorphan polistirex. There are twenty-three drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the dextromethorphan polistirex profile page.
Summary for 203133
Tradename:DEXTROMETHORPHAN POLISTIREX
Applicant:Amneal
Ingredient:dextromethorphan polistirex
Patents:0
Pharmacology for NDA: 203133
Medical Subject Heading (MeSH) Categories for 203133
Suppliers and Packaging for NDA: 203133
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROMETHORPHAN POLISTIREX dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 203133 ANDA Amneal Pharmaceuticals LLC 65162-700 65162-700-76 1 BOTTLE in 1 CARTON (65162-700-76) / 89 mL in 1 BOTTLE
DEXTROMETHORPHAN POLISTIREX dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE;ORAL 203133 ANDA Amneal Pharmaceuticals LLC 65162-700 65162-700-77 1 BOTTLE in 1 CARTON (65162-700-77) / 148 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION, EXTENDED RELEASE;ORALStrengthEQ 30MG HYDROBROMIDE/5ML
Approval Date:Jul 28, 2017TE:RLD:No

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