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 BIONPHARMA INC
New Drug Application (NDA): 022429
Company: BIONPHARMA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Over-the-counter |
None |
Yes | No |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter |
None |
Yes | Yes |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter |
None |
Yes | Yes |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Over-the-counter |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 07/23/2009 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022429_cetirizine_hydrochloride_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/07/2020 | SUPPL-17 | Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022429Orig1s017ltr.pdf |
|
| 12/13/2019 | SUPPL-14 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022429Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022429Orig1s014ltr.pdf |
||
| 02/06/2013 | SUPPL-9 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022429Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022429Orig1s009ltr.pdf |
||
| 04/06/2010 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022429s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/13/2019 | SUPPL-14 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022429Orig1s014lbl.pdf | |
| 02/06/2013 | SUPPL-9 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022429Orig1s009lbl.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.
CAPSULE;ORAL; 5MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Over-the-counter | Yes | 022429 | BIONPHARMA INC |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Over-the-counter | Yes | 022429 | BIONPHARMA INC |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CAPSULE;ORAL; 10MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | No | 207235 | APOTEX |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | No | 209107 | AUROBINDO PHARMA LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | Yes | 022429 | BIONPHARMA INC |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | No | 205291 | STRIDES PHARMA |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | No | 209107 | AUROBINDO PHARMA LTD |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | Yes | 022429 | BIONPHARMA INC |
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CAPSULE;ORAL; 5MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Over-the-counter | Yes | 022429 | BIONPHARMA INC |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Over-the-counter | Yes | 022429 | BIONPHARMA INC |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CAPSULE;ORAL; 10MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | No | 207235 | APOTEX |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | No | 209107 | AUROBINDO PHARMA LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | Yes | 022429 | BIONPHARMA INC |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | No | 205291 | STRIDES PHARMA |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | No | 209107 | AUROBINDO PHARMA LTD |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Over-the-counter | Yes | 022429 | BIONPHARMA INC |
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