Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205136
Company: HERITAGE

Products on ANDA 205136

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET;ORAL	Discontinued	None	No	No
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Discontinued	None	No	No
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205136

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/22/2019	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
12/10/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205136

MECLIZINE HYDROCHLORIDE

TABLET;ORAL; 50MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANTIVERT	MECLIZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	Yes	AA	010721	CASPER PHARMA LLC
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	201451	AMNEAL PHARMS
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	202640	AUROBINDO PHARMA USA
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	203003	CHARTWELL RX
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	205136	HERITAGE