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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211556
Company: HIBROW HLTHCARE

Products on ANDA 211556

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET;ORAL	Prescription	AB	No	No
ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211556

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/18/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/25/2025	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
08/16/2023	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211556

ACETAZOLAMIDE

TABLET;ORAL; 125MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET;ORAL	Prescription	No	AB	212089	AUROBINDO PHARMA LTD
ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET;ORAL	Prescription	No	AB	218023	EPIC PHARMA LLC
ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET;ORAL	Prescription	No	AB	205530	HERITAGE PHARMA
ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET;ORAL	Prescription	No	AB	211556	HIBROW HLTHCARE
ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET;ORAL	Prescription	No	AB	214282	MANKIND PHARMA
ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET;ORAL	Prescription	No	AB	217197	NE RX PHARMA
ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET;ORAL	Prescription	No	AB	210588	NOVITIUM PHARMA
ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET;ORAL	Prescription	No	AB	215101	RUBICON RESEARCH
ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET;ORAL	Prescription	No	AB	211372	SOMERSET THERAPS LLC
ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET;ORAL	Prescription	No	AB	209734	STRIDES PHARMA
ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET;ORAL	Prescription	No	AB	040195	TARO
ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET;ORAL	Prescription	No	AB	211069	ZYDUS LIFESCIENCES

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET;ORAL	Prescription	No	AB	212089	AUROBINDO PHARMA LTD
ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET;ORAL	Prescription	No	AB	084840	CHARTWELL MOLECULAR
ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET;ORAL	Prescription	No	AB	218023	EPIC PHARMA LLC
ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET;ORAL	Prescription	No	AB	205530	HERITAGE PHARMA
ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET;ORAL	Prescription	No	AB	211556	HIBROW HLTHCARE
ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET;ORAL	Prescription	No	AB	214282	MANKIND PHARMA
ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET;ORAL	Prescription	No	AB	217197	NE RX PHARMA
ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET;ORAL	Prescription	No	AB	210588	NOVITIUM PHARMA
ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET;ORAL	Prescription	No	AB	215101	RUBICON RESEARCH
ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET;ORAL	Prescription	No	AB	211372	SOMERSET THERAPS LLC
ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET;ORAL	Prescription	No	AB	209734	STRIDES PHARMA
ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET;ORAL	Prescription	No	AB	040195	TARO
ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET;ORAL	Prescription	No	AB	211069	ZYDUS LIFESCIENCES

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