Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022578
Company: J AND J CONSUMER INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/03/2010 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Letter (PDF)
Review
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022578s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022578s000_zyrtec_allergy_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022578Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/23/2016 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022578Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022578Orig1s007ltr.pdf
08/01/2016 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/21/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/24/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/01/2011 SUPPL-1 Labeling-Proprietary Name Change Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022578s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/23/2016 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022578Orig1s007lbl.pdf

ZYRTEC ALLERGY

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, ORALLY DISINTEGRATING;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter No 205490 PERRIGO R AND D
ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Over-the-counter Yes 022578 J AND J CONSUMER INC

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