Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019835
Company: J AND J CONSUMER INC

Products on NDA 19835

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET;ORAL	Discontinued	None	Yes	No
ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Over-the-counter	None	Yes	Yes
ZYRTEC HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG	TABLET;ORAL	Discontinued	None	Yes	No
ZYRTEC HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Discontinued	None	Yes	No

Labels for NDA 019835

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/08/2023	SUPPL-45	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019835Orig1s045lbl.pdf
08/07/2019	SUPPL-40	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019835Orig1s040lbl.pdf
09/10/2012	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019835s032lbl.pdf
03/17/2004	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19835slr016,21150slr005,30346slr011_zyrtec_lbl.pdf
10/21/2002	SUPPL-15	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19835s15,%2020346s8lbl.pdf