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 CETIRIZINE HYDROCHLORIDE ALLERGY از شرکت QUAGEN
Abbreviated New Drug Application (ANDA): 212266
Company: QUAGEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Over-the-counter |
None |
No | 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 |
|---|---|---|---|---|---|---|---|
| 05/16/2019 | ORIG-1 | Approval |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212266s000lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/16/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212266s000lbl.pdf |
CHILDREN’S CETIRIZINE HYDROCHLORIDE 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 |
منبع : www.accessdata.fda.gov
نظرات کاربران