Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 10721

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

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