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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 011265


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NDA 011265 describes PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, which is a drug marketed by Amneal Pharms, Ani Pharms, Hikma, and Tris Pharma Inc, and is included in four NDAs. It is available from five suppliers. Additional details are available on the PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE profile page.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-three drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.
Suppliers and Packaging for NDA: 011265
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 011265 NDA AUTHORIZED GENERIC ANI Pharmaceuticals, Inc. 62559-758 62559-758-04 118 mL in 1 BOTTLE (62559-758-04)
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 011265 NDA AUTHORIZED GENERIC ANI Pharmaceuticals, Inc. 62559-758 62559-758-16 473 mL in 1 BOTTLE (62559-758-16)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Apr 2, 1984TE:AARLD:Yes

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