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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 040902


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NDA 040902 describes PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE profile page.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE is phenylephrine hydrochloride; promethazine hydrochloride. There are twenty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 040902
Tradename:PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
Applicant:Amneal Pharms
Ingredient:phenylephrine hydrochloride; promethazine hydrochloride
Patents:0
Pharmacology for NDA: 040902
Mechanism of ActionAdrenergic alpha1-Agonists
Suppliers and Packaging for NDA: 040902
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 040902 ANDA Amneal Pharmaceuticals LLC 65162-679 65162-679-86 118 mL in 1 BOTTLE (65162-679-86)
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 040902 ANDA Amneal Pharmaceuticals LLC 65162-679 65162-679-90 473 mL in 1 BOTTLE (65162-679-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength5MG/5ML;6.25MG/5ML
Approval Date:Aug 25, 2009TE:AARLD:No

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Preferred Citation:

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