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Last Updated: December 3, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200963


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NDA 200963 describes PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, 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,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE profile page.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Pharmacology for NDA: 200963
Suppliers and Packaging for NDA: 200963
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 200963 ANDA Amneal Pharmaceuticals LLC 65162-694 65162-694-86 118 mL in 1 BOTTLE (65162-694-86)
PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 200963 ANDA Amneal Pharmaceuticals LLC 65162-694 65162-694-90 473 mL in 1 BOTTLE (65162-694-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength10MG/5ML;5MG/5ML;6.25MG/5ML
Approval Date:Aug 26, 2015TE:AARLD:No

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