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Generated: November 15, 2018

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Details for New Drug Application (NDA): 005939

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NDA 005939 describes BAL, which is a drug marketed by Akorn, B Braun, Avion Pharms, Solvay, Apotex Inc, Mylan, West-ward Pharms Int, Par Pharm Inc, and Barr, and is included in eleven NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the BAL profile page.

The generic ingredient in BAL is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 005939
Tradename:BAL
Applicant:Akorn
Ingredient:dimercaprol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 005939
Mechanism of ActionMetal Chelating Activity
Medical Subject Heading (MeSH) Categories for 005939
Suppliers and Packaging for NDA: 005939
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BAL dimercaprol INJECTABLE;INJECTION 005939 NDA Akorn, Inc. 17478-526 17478-526-03 10 AMPULE in 1 CARTON (17478-526-03) > 3 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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