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
ALLEGRA ALLERGY از شرکت SANOFI AVENTIS US
New Drug Application (NDA): 020872
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Over-the-counter |
None |
Yes | No |
| ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Over-the-counter |
None |
Yes | Yes |
| ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET;ORAL | Discontinued |
None |
Yes | No |
| ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET;ORAL | Discontinued |
None |
Yes | No |
| CHILDREN’S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
None |
Yes | No |
| CHILDREN’S ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET;ORAL | Discontinued |
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 |
|---|---|---|---|---|---|---|---|
| 02/25/2000 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20872lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/10/2016 | SUPPL-38 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020872Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020872Orig1s038ltr.pdf |
||
| 03/23/2016 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/2015 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/2015 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/2014 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/2014 | SUPPL-32 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020872Orig1s032ltr.pdf |
||
| 04/16/2014 | SUPPL-31 | Manufacturing (CMC) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s031bl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020872Orig1s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020872Orig1s031.pdf |
||
| 04/16/2013 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/23/2012 | SUPPL-29 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020872Orig1s029ltr.pdf |
||
| 02/23/2012 | SUPPL-25 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020872s025ltr.pdf |
||
| 01/24/2011 | SUPPL-23 | Efficacy-Rx To OTC Switch |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020872Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020872s023ltr.pdf |
||
| 06/25/2008 | SUPPL-18 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020872s018,021963s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021963s002, 020872s018ltr.pdf |
||
| 10/13/2005 | SUPPL-15 | Efficacy-New Dosing Regimen |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020872s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020872s015ltr.pdf |
||
| 05/12/2003 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20786se8-014,20872se8-011,20625se8-012ltr.pdf |
||
| 10/10/2002 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s010_ALLEGRA_TABLETS.pdf |
|
| 12/10/2002 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s009_ALLEGRA_TABLETS.pdf |
|
| 02/20/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s008_ALLEGRA_TABLETS.pdf |
|
| 07/11/2001 | SUPPL-7 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20625s11ltr.pdf |
|
| 01/05/2001 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020872_s005_ALLEGRA_TABLETS.pdf |
|
| 05/30/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf |
|
| 05/12/2003 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20872se8-003,20625se8-010_allegra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20872se8-003,20625se8-010ltr.pdf |
||
| 03/21/2000 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf |
|
| 04/14/2000 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/10/2016 | SUPPL-38 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020872Orig1s038lbl.pdf | |
| 09/12/2014 | SUPPL-32 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s032lbl.pdf | |
| 04/16/2014 | SUPPL-31 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s031bl.pdf |
| 08/23/2012 | SUPPL-29 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s029lbl.pdf | |
| 02/23/2012 | SUPPL-25 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s025lbl.pdf | |
| 01/24/2011 | SUPPL-23 |
Efficacy-Rx To OTC Switch |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020872Orig1s023lbl.pdf | |
| 06/25/2008 | SUPPL-18 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020872s018,021963s002lbl.pdf | |
| 10/13/2005 | SUPPL-15 |
Efficacy-New Dosing Regimen |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020872s015lbl.pdf | |
| 05/12/2003 | SUPPL-11 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf | |
| 05/12/2003 | SUPPL-3 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20872se8-003,20625se8-010_allegra_lbl.pdf | |
| 02/25/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20872lbl.pdf |
ALLEGRA 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 |
ALLEGRA HIVES
There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.
CHILDREN’S ALLEGRA ALLERGY
There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.
CHILDREN’S ALLEGRA HIVES
There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.
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