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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 040649


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NDA 040649 describes PROMETHAZINE DM, which is a drug marketed by Pai Holdings and is included in one NDA. It is available from seven suppliers. Additional details are available on the PROMETHAZINE DM profile page.

The generic ingredient in PROMETHAZINE DM is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.
Summary for 040649
Tradename:PROMETHAZINE DM
Applicant:Pai Holdings
Ingredient:dextromethorphan hydrobromide; promethazine hydrochloride
Patents:0
Pharmacology for NDA: 040649
Mechanism of ActionSigma-1 Receptor Agonists
Uncompetitive NMDA Receptor Antagonists
Suppliers and Packaging for NDA: 040649
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE DM dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 040649 ANDA PAI Holdings, LLC dba PAI Pharma 0121-1070 0121-1070-04 118 mL in 1 BOTTLE (0121-1070-04)
PROMETHAZINE DM dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 040649 ANDA PAI Holdings, LLC dba PAI Pharma 0121-1070 0121-1070-16 473 mL in 1 BOTTLE (0121-1070-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength15MG/5ML;6.25MG/5ML
Approval Date:Feb 14, 2006TE:AARLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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