Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200880
Company: MYLAN ASI

Products on ANDA 200880

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 200880

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/09/2012	ORIG-1	Approval	Not Applicable		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/200880Orig1s000Approv.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/25/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200880

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	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