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 NOVEL LABS INC
Abbreviated New Drug Application (ANDA): 206793
Company: NOVEL LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE;ORAL | Over-the-counter |
None |
No | No |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE;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 |
|---|---|---|---|---|---|---|---|
| 03/08/2016 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
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.
TABLET, CHEWABLE;ORAL; 5MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 091116 | JUBILANT GENERICS |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 206793 | NOVEL LABS INC |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 078692 | SANDOZ |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 090142 | SUN PHARM |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 091116 | JUBILANT GENERICS |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 090142 | SUN PHARM |
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 ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 090142 | SUN PHARM |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 091116 | JUBILANT GENERICS |
| CHILDREN’S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 090142 | SUN PHARM |
حتما بخوانید : BUTALBITAL, ACETAMINOPHEN AND CAFFEINE از شرکت WATSON LABS
منبع : www.accessdata.fda.gov
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