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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010721
Company: CASPER PHARMA LLC

Products on NDA 010721

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010721

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/14/1957	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
06/28/2019	SUPPL-63	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010721s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/010721Orig1s063ltr.pdf
12/12/2018	SUPPL-62	Labeling-Container/Carton Labels	Label (PDF) Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/010721Orig1s062_CartonLbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017210s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/010721Orig1s062ltr.pdf
04/13/2018	SUPPL-61	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/010721s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/010721Orig1s061ltr.pdf
10/23/2012	SUPPL-58	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/010721s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/010721Orig1s058ltr.pdf
12/14/1999	SUPPL-54	Manufacturing (CMC)-Formulation		Label is not available on this site.
11/10/1999	SUPPL-53	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/02/1993	SUPPL-52	Manufacturing (CMC)		Label is not available on this site.
09/17/1993	SUPPL-51	Manufacturing (CMC)		Label is not available on this site.
03/12/1993	SUPPL-50	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 010721

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2019	SUPPL-63	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010721s063lbl.pdf
12/12/2018	SUPPL-62	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/010721Orig1s062_CartonLbl.pdf
12/12/2018	SUPPL-62	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017210s062lbl.pdf
04/13/2018	SUPPL-61	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/010721s061lbl.pdf
10/23/2012	SUPPL-58	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/010721s058lbl.pdf

Therapeutic Equivalents for NDA 010721

ANTIVERT

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

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, CHEWABLE;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, CHEWABLE;ORAL	Prescription	Yes	AA	010721	CASPER PHARMA LLC

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

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