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Last Updated: August 13, 2020

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Acetazolamide sodium - Generic Drug Details

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What are the generic sources for acetazolamide sodium and what is the scope of freedom to operate?

Acetazolamide sodium is the generic ingredient in two branded drugs marketed by Emcure Pharms Ltd, Hospira, Mylan Asi, Par Sterile Products, West-ward Pharms Int, Xgen Pharms, Zydus Pharms, and Teva Womens, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for acetazolamide sodium. Five suppliers are listed for this compound.

Recent Clinical Trials for acetazolamide sodium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Azienda Unità Sanitaria Locale Reggio EmiliaPhase 4
Azienda USL di ParmaPhase 4
Azienda Ospedaliero-Universitaria di ParmaPhase 4

See all acetazolamide sodium clinical trials

Pharmacology for acetazolamide sodium

US Patents and Regulatory Information for acetazolamide sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira ACETAZOLAMIDE SODIUM acetazolamide sodium INJECTABLE;INJECTION 040108-001 Oct 30, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Zydus Pharms ACETAZOLAMIDE SODIUM acetazolamide sodium INJECTABLE;INJECTION 206533-001 Apr 15, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Par Sterile Products ACETAZOLAMIDE SODIUM acetazolamide sodium INJECTABLE;INJECTION 205358-001 Jun 20, 2017 DISCN No No   Start Trial   Start Trial   Start Trial
Teva Womens DIAMOX acetazolamide sodium INJECTABLE;INJECTION 009388-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Xgen Pharms ACETAZOLAMIDE SODIUM acetazolamide sodium INJECTABLE;INJECTION 040784-001 Dec 10, 2008 AP RX No Yes   Start Trial   Start Trial   Start Trial
Emcure Pharms Ltd ACETAZOLAMIDE SODIUM acetazolamide sodium INJECTABLE;INJECTION 202693-001 Dec 19, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Asi ACETAZOLAMIDE SODIUM acetazolamide sodium INJECTABLE;INJECTION 200880-001 May 9, 2012 AP RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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