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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219775
Company: GLAND

Products on ANDA 219775

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAZOLAMIDE SODIUM	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219775

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219775

ACETAZOLAMIDE SODIUM

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACETAZOLAMIDE SODIUM	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	202693	AVET LIFESCIENCES
ACETAZOLAMIDE SODIUM	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	219775	GLAND
ACETAZOLAMIDE SODIUM	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	040089	HIKMA
ACETAZOLAMIDE SODIUM	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	200880	MYLAN ASI
ACETAZOLAMIDE SODIUM	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	040784	XGEN PHARMS
ACETAZOLAMIDE SODIUM	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206533	ZYDUS PHARMS

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