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 ALLERGY از شرکت PERRIGO R AND D
Abbreviated New Drug Application (ANDA): 205490
Company: PERRIGO R AND D
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE ALLERGY | 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 |
|---|---|---|---|---|---|---|---|
| 09/02/2015 | ORIG-1 | Approval |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205490Orig1s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/28/2016 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/02/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205490Orig1s000lbl.pdf |
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, 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 |
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