Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021150
Company: J AND J CONSUMER INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYRTEC-D 12 HOUR CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE;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
08/10/2001 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21150lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21150ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-150_Zyrtec-D.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/09/2016 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/03/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/12/2014 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/23/2013 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/09/2007 SUPPL-7 Efficacy-Rx To OTC Switch Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/21150s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021150s007TOC.cfm
03/17/2004 SUPPL-5 Labeling Label (PDF)
Letter (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
04/14/2003 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21150se8-002_zyrtec_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21150se8-002ltr.pdf
02/14/2002 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-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19835slr016,21150slr005,30346slr011_zyrtec_lbl.pdf
04/14/2003 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21150se8-002_zyrtec_lbl.pdf
08/10/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21150lbl.pdf

ZYRTEC-D 12 HOUR

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

TABLET, EXTENDED RELEASE;ORAL; 5MG;120MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 077170 IVAX SUB TEVA PHARMS
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 210719 PERRIGO R AND D
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 077991 PLD ACQUISITIONS
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 090922 SUN PHARM INDS LTD
ZYRTEC-D 12 HOUR CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 021150 J AND J CONSUMER INC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English