Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021150
Company: J AND J CONSUMER INC
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 |
---|---|---|---|---|---|
11/03/2021 | SUPPL-21 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021150Orig1s021bl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021150Orig1s021ltr.pdf | |
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 |
---|---|---|---|---|---|
11/03/2021 | SUPPL-21 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021150Orig1s021bl.pdf | |
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 |