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Last Updated: June 9, 2023

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, Hikma, Mylan, Strides Pharma, Janssen Biotech, and Barr, and is included in twelve NDAs. It is available from one supplier. There are six patents 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. Fourteen 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 Action	Metal Chelating Activity

Medical Subject Heading (MeSH) Categories for 005939

Chelating Agents

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	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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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Serving leading biopharmaceutical companies globally:

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