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
CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY از شرکت SUN PHARM INDS
Abbreviated New Drug Application (ANDA): 091567
Company: SUN PHARM INDS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter |
None |
No | No |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter |
None |
No | No |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter |
None |
No | No |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter |
None |
No | No |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter |
None |
No | No |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/06/2012 | 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 |
|---|---|---|---|---|---|
| 02/25/2015 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
CHILDREN’S FEXOFENADINE 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; 30MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 202039 | AUROLIFE PHARMA LLC |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 076502 | DR REDDYS LABS LTD |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 204097 | HETERO LABS LTD V |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 091567 | SUN PHARM INDS |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 076447 | TEVA |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 079112 | WOCKHARDT LTD |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 076502 | DR REDDYS LABS LTD |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 091567 | SUN PHARM INDS |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 076447 | TEVA |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 079112 | WOCKHARDT LTD |
CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 30MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 202039 | AUROLIFE PHARMA LLC |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 076502 | DR REDDYS LABS LTD |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 204097 | HETERO LABS LTD V |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 091567 | SUN PHARM INDS |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 076447 | TEVA |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 079112 | WOCKHARDT LTD |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 076502 | DR REDDYS LABS LTD |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 091567 | SUN PHARM INDS |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 076447 | TEVA |
| CHILDREN’S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Over-the-counter | No | 079112 | WOCKHARDT LTD |
FEXOFENADINE 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; 60MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | Yes | 020872 | SANOFI AVENTIS US |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 212971 | L PERRIGO CO |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 202039 | AUROLIFE PHARMA LLC |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 076502 | DR REDDYS LABS LTD |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 211075 | GRANULES |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 204097 | HETERO LABS LTD V |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 077081 | MYLAN |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 204507 | SCIEGEN PHARMS INC |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 091567 | SUN PHARM INDS |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 076447 | TEVA |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 079112 | WOCKHARDT LTD |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 076502 | DR REDDYS LABS LTD |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 077081 | MYLAN |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 204507 | SCIEGEN PHARMS INC |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 091567 | SUN PHARM INDS |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 076447 | TEVA |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 079112 | WOCKHARDT 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; 180MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | Yes | 020872 | SANOFI AVENTIS US |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 212971 | L PERRIGO CO |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 202039 | AUROLIFE PHARMA LLC |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 076502 | DR REDDYS LABS LTD |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 211075 | GRANULES |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 204097 | HETERO LABS LTD V |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 077081 | MYLAN |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 204507 | SCIEGEN PHARMS INC |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 091567 | SUN PHARM INDS |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 076447 | TEVA |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 210137 | UNIQUE PHARM LABS |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 079112 | WOCKHARDT LTD |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 076502 | DR REDDYS LABS LTD |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 077081 | MYLAN |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 204507 | SCIEGEN PHARMS INC |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 091567 | SUN PHARM INDS |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 076447 | TEVA |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 079112 | WOCKHARDT LTD |
FEXOFENADINE HYDROCHLORIDE HIVES
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 60MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | Yes | 020872 | SANOFI AVENTIS US |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 212971 | L PERRIGO CO |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 202039 | AUROLIFE PHARMA LLC |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 076502 | DR REDDYS LABS LTD |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 211075 | GRANULES |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 204097 | HETERO LABS LTD V |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 077081 | MYLAN |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 204507 | SCIEGEN PHARMS INC |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 091567 | SUN PHARM INDS |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 076447 | TEVA |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 079112 | WOCKHARDT LTD |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 076502 | DR REDDYS LABS LTD |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 077081 | MYLAN |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 204507 | SCIEGEN PHARMS INC |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 091567 | SUN PHARM INDS |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 076447 | TEVA |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter | No | 079112 | WOCKHARDT 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; 180MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | Yes | 020872 | SANOFI AVENTIS US |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 212971 | L PERRIGO CO |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 202039 | AUROLIFE PHARMA LLC |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 076502 | DR REDDYS LABS LTD |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 211075 | GRANULES |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 204097 | HETERO LABS LTD V |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 077081 | MYLAN |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 204507 | SCIEGEN PHARMS INC |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 091567 | SUN PHARM INDS |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 076447 | TEVA |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 210137 | UNIQUE PHARM LABS |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 079112 | WOCKHARDT LTD |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 076502 | DR REDDYS LABS LTD |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 077081 | MYLAN |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 204507 | SCIEGEN PHARMS INC |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 091567 | SUN PHARM INDS |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 076447 | TEVA |
| FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter | No | 079112 | WOCKHARDT LTD |
حتما بخوانید : ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE از شرکت NEPHRON
منبع : www.accessdata.fda.gov
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