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Last Updated: March 28, 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, Hikma, Hospira, Mylan Asi, Par Sterile Products, Xgen Pharms, and Zydus Pharms, and is included in seven NDAs. It is available from seven 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. Seven 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
Formulation / Manufacturing:see details
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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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. 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.