Drugs@FDA: FDA Approved Drug Products

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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/08/1995 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019835Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/08/2017 SUPPL-39 Labeling-Container/Carton Labels

Label is not available on this site.

04/04/2016 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

01/20/2015 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

09/26/2014 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

09/10/2012 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019835s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019835Orig1s032ltr.pdf
03/13/2012 SUPPL-30 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019835s030ltr.pdf
01/26/2012 SUPPL-29 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019835s029ltr.pdf
02/26/2010 SUPPL-28 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019835s028ltr.pdf
02/26/2010 SUPPL-26 Labeling

Label is not available on this site.

11/25/2008 SUPPL-25 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019835s025ltr.pdf
11/16/2007 SUPPL-22 Efficacy-Rx To OTC Switch Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019835s022_CKD.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/019835s022_021621s005TOC.cfm
04/04/2006 SUPPL-20 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019835s020ltr.pdf
03/17/2004 SUPPL-16 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/2002/019835_S016_ZYRTEC SYRUP_.pdf
10/21/2002 SUPPL-15 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/2002/019835_S015_ZYRTEC TABLETS.pdf
09/19/2000 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/25/2000 SUPPL-10 Labeling

Label is not available on this site.

02/04/2000 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/09/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/27/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/22/1998 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1998 SUPPL-5 Efficacy-New Indication Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19835s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19835-S005_Zyrtec.pdf
11/01/1996 SUPPL-4 Labeling

Label is not available on this site.

11/14/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1996 SUPPL-2 Labeling

Label is not available on this site.

05/23/1996 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
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

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;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078780 AMNEAL PHARMS NY
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078317 APOTEX INC
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 090760 AUROBINDO PHARMA LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077318 CIPLA LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 076047 CONTRACT PHARMACAL
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078343 DR REDDYS LABS LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 209274 GRANULES INDIA LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 202277 IPCA LABS LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078933 MARKSANS PHARMA
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 076677 MYLAN
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078862 ORCHID HLTHCARE
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078336 PERRIGO R AND D
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077946 PLD ACQUISITIONS
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077499 SUN PHARM INDS INC
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077498 SUN PHARM INDS LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 079191 TORRENT PHARMS LLC
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078680 UNICHEM
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077829 UNIQUE PHARM LABS
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078427 WOCKHARDT
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078343 DR REDDYS LABS LTD
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 202277 IPCA LABS LTD
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078933 MARKSANS PHARMA
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 076677 MYLAN
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078862 ORCHID HLTHCARE
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078336 PERRIGO R AND D
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077499 SUN PHARM INDS INC
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077498 SUN PHARM INDS LTD
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078680 UNICHEM
CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 077829 UNIQUE PHARM LABS
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078780 AMNEAL PHARMS NY
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 090760 AUROBINDO PHARMA LTD
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 078072 TARO
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter No 079191 TORRENT PHARMS LLC
ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET;ORAL Over-the-counter Yes 019835 J AND J CONSUMER INC

ZYRTEC HIVES RELIEF

There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.

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