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 APOTEX INC
Abbreviated New Drug Application (ANDA): 078317
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter |
None |
No | No |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 12/27/2007 | ORIG-1 | Approval |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078317lbl_rc.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/27/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078317lbl_rc.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;ORAL; 5MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078780 | AMNEAL PHARMS NY |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078317 | APOTEX INC |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 090760 | AUROBINDO PHARMA LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 076047 | CONTRACT PHARMACAL |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078343 | DR REDDYS LABS LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 202277 | IPCA LABS LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078933 | MARKSANS PHARMA |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 076677 | MYLAN |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078862 | ORCHID HLTHCARE |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078336 | PERRIGO R AND D |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 077946 | PLD ACQUISITIONS |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 077498 | SUN PHARM INDS LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078072 | TARO |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 077829 | UNIQUE PHARM LABS |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078427 | WOCKHARDT |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078343 | DR REDDYS LABS LTD |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 202277 | IPCA LABS LTD |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078933 | MARKSANS PHARMA |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 076677 | MYLAN |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078862 | ORCHID HLTHCARE |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078336 | PERRIGO R AND D |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 077498 | SUN PHARM INDS LTD |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 077829 | UNIQUE PHARM LABS |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 078780 | AMNEAL PHARMS NY |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Over-the-counter | No | 090760 | AUROBINDO PHARMA LTD |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 10MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078780 | AMNEAL PHARMS NY |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078317 | APOTEX INC |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 090760 | AUROBINDO PHARMA LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 076047 | CONTRACT PHARMACAL |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078343 | DR REDDYS LABS LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 209274 | GRANULES |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 202277 | IPCA LABS LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078933 | MARKSANS PHARMA |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 076677 | MYLAN |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078862 | ORCHID HLTHCARE |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078336 | PERRIGO R AND D |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 077946 | PLD ACQUISITIONS |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 077498 | SUN PHARM INDS LTD |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 077829 | UNIQUE PHARM LABS |
| CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078427 | WOCKHARDT |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078343 | DR REDDYS LABS LTD |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 202277 | IPCA LABS LTD |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078933 | MARKSANS PHARMA |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 076677 | MYLAN |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078862 | ORCHID HLTHCARE |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078336 | PERRIGO R AND D |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 077498 | SUN PHARM INDS LTD |
| CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 077829 | UNIQUE PHARM LABS |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078780 | AMNEAL PHARMS NY |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 090760 | AUROBINDO PHARMA LTD |
| CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | No | 078072 | TARO |
| ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Over-the-counter | Yes | 019835 | J AND J CONSUMER INC |
حتما بخوانید : BUTABARBITAL SODIUM از شرکت SANDOZ
منبع : www.accessdata.fda.gov
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