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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 016931

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NDA 016931 describes R-GENE 10, which is a drug marketed by Pharmacia And Upjohn and is included in one NDA. It is available from one supplier. Additional details are available on the R-GENE 10 profile page.

The generic ingredient in R-GENE 10 is arginine hydrochloride. There are thirty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the arginine hydrochloride profile page.
Summary for 016931
Tradename:R-GENE 10
Applicant:Pharmacia And Upjohn
Ingredient:arginine hydrochloride
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 016931
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
R-GENE 10 arginine hydrochloride INJECTABLE;INJECTION 016931 NDA Pharmacia and Upjohn Company LLC 0009-0436 0009-0436-01 1 CONTAINER in 1 CARTON (0009-0436-01) > 300 mL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10GM/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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