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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 200880


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NDA 200880 describes ACETAZOLAMIDE SODIUM, which is a drug marketed by Avet Lifesciences, Endo Operations, Hikma, Hospira, Mylan Asi, Xgen Pharms, and Zydus Pharms, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the ACETAZOLAMIDE SODIUM profile page.

The generic ingredient in ACETAZOLAMIDE SODIUM is acetazolamide sodium. There are ten drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acetazolamide sodium profile page.
Summary for 200880
Tradename:ACETAZOLAMIDE SODIUM
Applicant:Mylan Asi
Ingredient:acetazolamide sodium
Patents:0
Pharmacology for NDA: 200880
Mechanism of ActionCarbonic Anhydrase Inhibitors
Suppliers and Packaging for NDA: 200880
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAZOLAMIDE SODIUM acetazolamide sodium INJECTABLE;INJECTION 200880 ANDA Mylan Institutional LLC 67457-853 67457-853-50 1 VIAL in 1 CARTON (67457-853-50) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:May 9, 2012TE:APRLD:No

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