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 FEXOFENADINE HYDROCHLORIDE ALLERGY از شرکت P AND L
Abbreviated New Drug Application (ANDA): 203330
Company: P AND L
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter |
None |
No | No |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter |
None |
No | 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 |
|---|---|---|---|---|---|---|---|
| 11/18/2014 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/03/2020 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUSPENSION;ORAL; 30MG/5ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN’S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter | Yes | 201373 | SANOFI AVENTIS US |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 203330 | P AND L |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 208123 | TARO |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 203330 | P AND L |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 208123 | TARO |
CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUSPENSION;ORAL; 30MG/5ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN’S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter | Yes | 201373 | SANOFI AVENTIS US |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 203330 | P AND L |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 208123 | TARO |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 203330 | P AND L |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 208123 | TARO |
منبع : www.accessdata.fda.gov
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