Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200294
Company: EPIC PHARMA LLC

Products on ANDA 200294

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	No
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200294

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/13/2012	ORIG-1	Approval	Not Applicable		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/200294Orig1s000Approv.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2019	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/23/2019	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/23/2019	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/28/2012	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200294

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