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Drugs@FDA: FDA-Approved Drugs

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

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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/28/2024 SUPPL-47 Manufacturing (CMC)-Facility Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019835Orig1s047lbl.pdf
12/01/2023 SUPPL-46 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019835Orig1s046lbl.pdf
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
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