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): 022155
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/5ML | SYRUP;ORAL | Over-the-counter |
None |
Yes | Yes |
| CHILDREN’S ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 11/16/2007 | ORIG-1 | Approval |
Type 8 – Partial Rx to OTC Switch |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022155s000ltr_CKD.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/11/2018 | SUPPL-15 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022155Orig1015Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022155Orig1s015Ltr.pdf |
||
| 09/10/2015 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/2016 | SUPPL-10 | Manufacturing (CMC) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022155Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022155Orig1s010ltr.pdf |
||
| 05/16/2014 | SUPPL-9 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022155Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022155Orig1s009ltr.pdf |
||
| 05/22/2012 | SUPPL-7 | Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022155s007ltr.pdf |
|
| 03/13/2009 | SUPPL-6 | Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022155s006ltr.pdf |
|
| 03/04/2009 | SUPPL-5 | Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022155s005ltr.pdf |
|
| 08/14/2008 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022155s003ltr.pdf |
|
| 08/14/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022155s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/11/2018 | SUPPL-15 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022155Orig1015Lbl.pdf | |
| 04/14/2016 | SUPPL-10 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022155Orig1s010lbl.pdf |
| 05/16/2014 | SUPPL-9 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022155Orig1s009lbl.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.
SYRUP;ORAL; 5MG/5ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090765 | AMNEAL PHARMS |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 091327 | ATHEM |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090750 | AUROBINDO PHARMA |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 210622 | HETERO LABS LTD III |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 091130 | LANNETT CO INC |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090254 | PERRIGO R AND D |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 204226 | PERRIGO R AND D |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 212266 | QUAGEN |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090182 | TARO |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 201546 | TARO |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090572 | TRIS PHARMA INC |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090765 | AMNEAL PHARMS |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 091327 | ATHEM |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090750 | AUROBINDO PHARMA |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 091130 | LANNETT CO INC |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090254 | PERRIGO R AND D |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090182 | TARO |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 201546 | TARO |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090572 | TRIS PHARMA INC |
| CHILDREN’S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | Yes | 022155 | J AND J CONSUMER INC |
| CHILDREN’S ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | Yes | 022155 | J AND J CONSUMER INC |
CHILDREN’S ZYRTEC HIVES RELIEF
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SYRUP;ORAL; 5MG/5ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090765 | AMNEAL PHARMS |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 091327 | ATHEM |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090750 | AUROBINDO PHARMA |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 210622 | HETERO LABS LTD III |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 091130 | LANNETT CO INC |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090254 | PERRIGO R AND D |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 204226 | PERRIGO R AND D |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 212266 | QUAGEN |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090182 | TARO |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 201546 | TARO |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090572 | TRIS PHARMA INC |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090765 | AMNEAL PHARMS |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 091327 | ATHEM |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090750 | AUROBINDO PHARMA |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 091130 | LANNETT CO INC |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090254 | PERRIGO R AND D |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090182 | TARO |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 201546 | TARO |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | No | 090572 | TRIS PHARMA INC |
| CHILDREN’S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | Yes | 022155 | J AND J CONSUMER INC |
| CHILDREN’S ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter | Yes | 022155 | J AND J CONSUMER INC |
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