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 BRECKENRIDGE
Abbreviated New Drug Application (ANDA): 078488
Company: BRECKENRIDGE
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 | 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 |
---|---|---|---|---|---|---|---|
10/06/2008 | 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-6 | Labeling-Package Insert |
Label is not available on this site. |
||
11/08/2016 | SUPPL-5 | 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 |
حتما بخوانید : CETIRIZINE HYDROCHLORIDE از شرکت PHARM ASSOC
منبع : www.accessdata.fda.gov
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