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
CETIRIZINE HYDROCHLORIDE از شرکت AUROBINDO PHARMA LTD
Abbreviated New Drug Application (ANDA): 213557
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, ORALLY DISINTEGRATING;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 |
|---|---|---|---|---|---|---|---|
| 09/11/2020 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
CETIRIZINE HYDROCHLORIDE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, ORALLY DISINTEGRATING;ORAL; 10MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 213557 | AUROBINDO PHARMA LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | No | 205490 | PERRIGO R AND D |
| ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Over-the-counter | Yes | 022578 | J AND J CONSUMER INC |
نظرات کاربران