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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 drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride; promethazine hydrochloride profile page.

Summary for NDA: 040902

Pharmacology for NDA: 040902

Ingredient-typePhenothiazines
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 of New York, 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 of New York, LLC 65162-679 65162-679-90 473 mL in 1 BOTTLE (65162-679-90)

Summary 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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