Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022155
Company: J AND J CONSUMER INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter None Yes Yes
CHILDREN'S ZYRTEC HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;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
11/16/2007 ORIG-1 Approval Type 8 - Partial Rx to OTC Switch STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022155s000ltr_CKD.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022155s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/11/2018 SUPPL-15 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022155Orig1015Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022155Orig1s015Ltr.pdf
09/10/2015 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/14/2016 SUPPL-10 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022155Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022155Orig1s010ltr.pdf
05/16/2014 SUPPL-9 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022155Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022155Orig1s009ltr.pdf
05/22/2012 SUPPL-7 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022155s007ltr.pdf
03/13/2009 SUPPL-6 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022155s006ltr.pdf
03/04/2009 SUPPL-5 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022155s005ltr.pdf
08/14/2008 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022155s003ltr.pdf
08/14/2008 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022155s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/11/2018 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022155Orig1015Lbl.pdf
04/14/2016 SUPPL-10 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022155Orig1s010lbl.pdf
05/16/2014 SUPPL-9 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022155Orig1s009lbl.pdf

CHILDREN'S ZYRTEC ALLERGY

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

SYRUP;ORAL; 5MG/5ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090765 AMNEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 091327 ATHEM
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090750 AUROBINDO PHARMA
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 210622 HETERO LABS LTD III
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 091130 LANNETT CO INC
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090254 PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 204226 PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090182 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 201546 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090474 TORRENT
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090572 TRIS PHARMA INC
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090765 AMNEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 091327 ATHEM
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090750 AUROBINDO PHARMA
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 091130 LANNETT CO INC
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090254 PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090182 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 201546 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090474 TORRENT
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090572 TRIS PHARMA INC
CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter Yes 022155 J AND J CONSUMER INC
CHILDREN'S ZYRTEC HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter Yes 022155 J AND J CONSUMER INC

CHILDREN'S ZYRTEC HIVES RELIEF

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

SYRUP;ORAL; 5MG/5ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090765 AMNEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 091327 ATHEM
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090750 AUROBINDO PHARMA
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 210622 HETERO LABS LTD III
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 091130 LANNETT CO INC
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090254 PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 204226 PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090182 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 201546 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090474 TORRENT
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090572 TRIS PHARMA INC
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090765 AMNEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 091327 ATHEM
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090750 AUROBINDO PHARMA
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 091130 LANNETT CO INC
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090254 PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090182 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 201546 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090474 TORRENT
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090572 TRIS PHARMA INC
CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter Yes 022155 J AND J CONSUMER INC
CHILDREN'S ZYRTEC HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter Yes 022155 J AND J CONSUMER INC

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