Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020346
Company: J AND J CONSUMER INC
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ZYRTEC CETIRIZINE HYDROCHLORIDE 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP;ORAL Discontinued None No No
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.

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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