Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201451
Company: AMNEAL PHARMS

Products on ANDA 201451

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET;ORAL	Prescription	AA	No	Yes
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	AA	No	Yes
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201451

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/23/2011	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/22/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
09/22/2023	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/22/2023	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/15/2013	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201451

MECLIZINE HYDROCHLORIDE

TABLET;ORAL; 12.5MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANTIVERT	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET;ORAL	Prescription	Yes	AA	010721	CASPER PHARMA LLC
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET;ORAL	Prescription	No	AA	201451	AMNEAL PHARMS
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET;ORAL	Prescription	No	AA	087128	APNAR PHARMA LP
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET;ORAL	Prescription	No	AA	202640	AUROBINDO PHARMA USA
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET;ORAL	Prescription	No	AA	203003	CHARTWELL RX
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET;ORAL	Prescription	No	AA	200294	EPIC PHARMA LLC
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET;ORAL	Prescription	No	AA	040659	JUBILANT CADISTA
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET;ORAL	Prescription	No	AA	084843	SANDOZ
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET;ORAL	Prescription	No	AA	205136	WILSHIRE PHARMS INC
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET;ORAL	Prescription	No	AA	213957	ZYDUS LIFESCIENCES

TABLET;ORAL; 25MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANTIVERT	MECLIZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	Yes	AA	010721	CASPER PHARMA LLC
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	201451	AMNEAL PHARMS
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	087128	APNAR PHARMA LP
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	202640	AUROBINDO PHARMA USA
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	203003	CHARTWELL RX
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	200294	EPIC PHARMA LLC
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	084092	INVATECH
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	040659	JUBILANT CADISTA
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	205136	WILSHIRE PHARMS INC
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	213957	ZYDUS LIFESCIENCES

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	WILSHIRE PHARMS INC