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Last Updated: September 21, 2020

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Details for New Drug Application (NDA): 211050

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NDA 211050 describes DIAZOXIDE, which is a drug marketed by Abraxis Pharm, E5 Pharma Inc, and Novitium Pharma, and is included in three NDAs. It is available from two suppliers. Additional details are available on the DIAZOXIDE profile page.

The generic ingredient in DIAZOXIDE is diazoxide. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the diazoxide profile page.
Summary for 211050
Tradename:DIAZOXIDE
Applicant:E5 Pharma Inc
Ingredient:diazoxide
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 211050
Suppliers and Packaging for NDA: 211050
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIAZOXIDE diazoxide SUSPENSION;ORAL 211050 ANDA e5 Pharma, LLC 13517-100 13517-100-30 1 BOTTLE, DROPPER in 1 CARTON (13517-100-30) > 30 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength50MG/ML
Approval Date:Dec 20, 2019TE:ABRLD:No
Regulatory Exclusivity Expiration:Jun 17, 2020
Regulatory Exclusivity Use:COMPETITIVE GENERIC THERAPY

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