Drugs@FDA: FDA-Approved Drugs
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ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL | Discontinued | None | Yes | No |
CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE;ORAL | Over-the-counter | None | Yes | No |
CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE;ORAL | Over-the-counter | None | Yes | No |
CHILDREN'S ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL | Discontinued | None | Yes | No |
CHILDREN'S ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
03/16/2004 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21621ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-621_Zyrtec.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/14/2021 | SUPPL-12 | Labeling-Proprietary Name Change, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021621Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021621Orig1s012ltr.pdf | |
11/30/2020 | SUPPL-10 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021621Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021621Orig1s010ltr.pdf | ||
11/16/2007 | SUPPL-5 | Efficacy-Rx To OTC Switch |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021621s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/019835s022_021621s005TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/14/2021 | SUPPL-12 | Labeling-Proprietary Name Change | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021621Orig1s012lbl.pdf | |
12/14/2021 | SUPPL-12 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021621Orig1s012lbl.pdf | |
11/30/2020 | SUPPL-10 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021621Orig1s010lbl.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.
TABLET, CHEWABLE;ORAL; 2.5MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE;ORAL | Over-the-counter | Yes | 021621 | J AND J CONSUMER INC |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, CHEWABLE;ORAL; 10MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 091116 | JUBILANT GENERICS |
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 206793 | NOVEL LABS INC |
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 078692 | SANDOZ |
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 091116 | JUBILANT GENERICS |
CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE;ORAL | Over-the-counter | Yes | 021621 | J AND J CONSUMER INC |
CHILDREN'S ZYRTEC HIVES RELIEF
There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.