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 PADAGIS US
Abbreviated New Drug Application (ANDA): 078398
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Prescription |
AA |
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 |
|---|---|---|---|---|---|---|---|
| 06/17/2008 | 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-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
CETIRIZINE HYDROCHLORIDE
SYRUP;ORAL; 5MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Prescription | No | AA | 090766 | AMNEAL PHARMS |
| CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Prescription | No | AA | 078488 | BRECKENRIDGE |
| CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Prescription | No | AA | 078876 | LANNETT CO INC |
| CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Prescription | No | AA | 090191 | MLV |
| CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Prescription | No | AA | 078398 | PADAGIS US |
| CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Prescription | No | AA | 076601 | TARO |
| CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SYRUP;ORAL | Prescription | No | AA | 077279 | TEVA PHARMS |
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