Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019835
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 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 |
|---|---|---|---|---|---|
| 11/26/2024 | SUPPL-50 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019835Orig1s050;22155Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019835Orig1s050;22155Orig1s027ltr.pdf | |
| 03/28/2024 | SUPPL-47 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019835Orig1s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019835Orig1s047ltr.pdf | |
| 12/01/2023 | SUPPL-46 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019835Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019835Orig1s046ltr.pdf | |
| 05/08/2023 | SUPPL-45 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019835Orig1s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019835Orig1s045ltr.pdf | |
| 08/07/2019 | SUPPL-40 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019835Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019835Orig1s040ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 11/26/2024 | SUPPL-50 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019835Orig1s050;22155Orig1s027lbl.pdf | |
| 11/26/2024 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019835Orig1s050;22155Orig1s027lbl.pdf | |
| 03/28/2024 | SUPPL-47 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019835Orig1s047lbl.pdf | |
| 12/01/2023 | SUPPL-46 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019835Orig1s046lbl.pdf | |
| 05/08/2023 | SUPPL-45 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019835Orig1s045lbl.pdf | |
| 08/07/2019 | SUPPL-40 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019835Orig1s040lbl.pdf | |
| 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 | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 218895 | INDOCO |
| 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 | 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 | 078427 | GLENMARK PHARMS INC |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 209274 | GRANULES |
| 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 | ORBION PHARMS |
| 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 | 077498 | SUN PHARM INDS LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 077829 | UNIQUE |
| 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 | ORBION PHARMS |
| 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 | 077498 | SUN PHARM INDS LTD |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 077829 | UNIQUE |
| 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 |
| 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.