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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020346
Company: J AND J CONSUMER INC

Products on NDA 020346

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZYRTEC	CETIRIZINE HYDROCHLORIDE	5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020346

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/1996	ORIG-1	Approval	Type 3 - New Dosage Form	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
03/17/2004	SUPPL-11	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19835slr016,21150slr005,30346slr011_zyrtec_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19835slr016,21150slr005,30346slr011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020346_S011_ZYRTEC SYRUP.pdf
07/19/2002	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
10/21/2002	SUPPL-8	Efficacy-New Patient Population	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19835s15,%2020346s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19835se5-015,20346se5-008LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020346_S008_ZYRTEC TABLETS.pdf
02/25/2000	SUPPL-6	Labeling		Label is not available on this site.
03/04/1999	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
06/10/1998	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
10/21/1997	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/15/1998	SUPPL-2	Efficacy-New Indication	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20346s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19835-S005_Zyrtec.pdf
04/18/1997	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020346

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/17/2004	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19835slr016,21150slr005,30346slr011_zyrtec_lbl.pdf
10/21/2002	SUPPL-8	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19835s15,%2020346s8lbl.pdf

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