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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
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Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040675

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NDA 040675 describes PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, which is a drug marketed by Hi-tech Pharmacal and Vintage and is included in two NDAs. It is available from five suppliers. Additional details are available on the PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE profile page.

The generic ingredient in PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE is phenylephrine hydrochloride; promethazine hydrochloride. There are twenty drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride; promethazine hydrochloride profile page.
Pharmacology for NDA: 040675
Ingredient-typePhenothiazines
Mechanism of ActionAdrenergic alpha1-Agonists
Suppliers and Packaging for NDA: 040675
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 040675 ANDA Hi-Tech Pharmacal Co., Inc. 50383-802 50383-802-16 473 mL in 1 BOTTLE (50383-802-16)
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 040675 ANDA Hi-Tech Pharmacal Co., Inc. 50383-802 50383-802-04 118 mL in 1 BOTTLE (50383-802-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength5MG/5ML;6.25MG/5ML
Approval Date:Dec 23, 2014TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Novartis
Cipla
Queensland Health
US Department of Justice
Daiichi Sankyo
Chinese Patent Office
Healthtrust
Accenture

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