Last Updated: November 8, 2026

Details for New Drug Application (NDA): 200880

« Back to Dashboard

NDA 200880 describes ACETAZOLAMIDE SODIUM, which is a drug marketed by Avet Lifesciences, Gland, Hikma, Hospira, Mylan Asi, Ph Health, Xgen Pharms, and Zydus Pharms, and is included in eight 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 is one drug master file entry 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 Action	Carbonic 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
ACETAZOLAMIDE SODIUM	acetazolamide sodium	INJECTABLE;INJECTION	200880	ANDA	Mylan Institutional LLC	72078-092	72078-092-50	1 VIAL in 1 CARTON (72078-092-50) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	May 9, 2012	TE:	AP	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.