اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CHILDREN’S ZYRTEC ALLERGY از شرکت J AND J CONSUMER INC
New Drug Application (NDA): 021621
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ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, CHEWABLE;ORAL | Discontinued |
None |
Yes | No |
| CHILDREN’S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, CHEWABLE;ORAL | Discontinued |
None |
Yes | No |
| CHILDREN’S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE;ORAL | Discontinued |
None |
Yes | No |
| CHILDREN’S ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, CHEWABLE;ORAL | Discontinued |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HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, CHEWABLE;ORAL | Discontinued |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 |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21621ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/30/2020 | SUPPL-10 |
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 |
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 |
|---|---|---|---|---|---|
| 11/30/2020 | SUPPL-10 |
Manufacturing (CMC) |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021621Orig1s010lbl.pdf |
نظرات کاربران