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Generated: January 19, 2019

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Details for New Drug Application (NDA): 017453

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NDA 017453 describes PROGLYCEM, which is a drug marketed by Teva Branded Pharm and is included in two NDAs. It is available from one supplier. Additional details are available on the PROGLYCEM profile page.

The generic ingredient in PROGLYCEM is diazoxide. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the diazoxide profile page.
Summary for 017453
Tradename:PROGLYCEM
Applicant:Teva Branded Pharm
Ingredient:diazoxide
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 017453
Suppliers and Packaging for NDA: 017453
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROGLYCEM diazoxide SUSPENSION;ORAL 017453 NDA Teva Pharmaceuticals USA, Inc. 0575-6200 0575-6200-30 1 BOTTLE, DROPPER in 1 BOX (0575-6200-30) > 30 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength50MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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