ALLEGRA ALLERGY از شرکت SANOFI AVENTIS US

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 NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET;ORALOver-the-counter

None

YesNo
ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALOver-the-counter

None

YesYes
ALLEGRA HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET;ORALDiscontinued

None

YesNo
ALLEGRA HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALDiscontinued

None

YesNo
CHILDREN’S ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDE30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET;ORALDiscontinued

None

YesNo
CHILDREN’S ALLEGRA HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET;ORALDiscontinued

None

YesNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
02/25/2000ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20872lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20872ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-872_Allegra.cfm

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
05/10/2016SUPPL-38 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020872Orig1s038lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020872Orig1s038ltr.pdf

03/23/2016SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

09/18/2015SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

09/24/2015SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/02/2014SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

09/12/2014SUPPL-32 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s032lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020872Orig1s032ltr.pdf

04/16/2014SUPPL-31 Manufacturing (CMC)

Label (PDF)

Letter (PDF)

Review (PDF)

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

04/16/2013SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

08/23/2012SUPPL-29 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s029lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020872Orig1s029ltr.pdf

02/23/2012SUPPL-25 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s025lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020872s025ltr.pdf

01/24/2011SUPPL-23 Efficacy-Rx To OTC Switch

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020872Orig1s023lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020872s023ltr.pdf

06/25/2008SUPPL-18 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020872s018,021963s002lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021963s002, 020872s018ltr.pdf

10/13/2005SUPPL-15 Efficacy-New Dosing Regimen

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020872s015lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020872s015ltr.pdf

05/12/2003SUPPL-11 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

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

10/10/2002SUPPL-10 Manufacturing (CMC)

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s010_ALLEGRA_TABLETS.pdf

12/10/2002SUPPL-9 Manufacturing (CMC)

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s009_ALLEGRA_TABLETS.pdf

02/20/2002SUPPL-8 Manufacturing (CMC)-Control

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s008_ALLEGRA_TABLETS.pdf

07/11/2001SUPPL-7 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20625s11ltr.pdf

01/05/2001SUPPL-5 Manufacturing (CMC)

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020872_s005_ALLEGRA_TABLETS.pdf

05/30/2001SUPPL-4 Manufacturing (CMC)-Control

Letter (PDF)

Review (PDF)

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

05/12/2003SUPPL-3 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

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

03/21/2000SUPPL-2 Manufacturing (CMC)-Packaging

Letter (PDF)

Review (PDF)

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

04/14/2000SUPPL-1 Manufacturing (CMC)

Letter (PDF)

Review (PDF)

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 DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
05/10/2016SUPPL-38

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020872Orig1s038lbl.pdf
09/12/2014SUPPL-32

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s032lbl.pdf
04/16/2014SUPPL-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
08/23/2012SUPPL-29

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s029lbl.pdf
02/23/2012SUPPL-25

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s025lbl.pdf
01/24/2011SUPPL-23

Efficacy-Rx To OTC Switch

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020872Orig1s023lbl.pdf
06/25/2008SUPPL-18

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020872s018,021963s002lbl.pdf
10/13/2005SUPPL-15

Efficacy-New Dosing Regimen

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020872s015lbl.pdf
05/12/2003SUPPL-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
05/12/2003SUPPL-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
02/25/2000ORIG-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 NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDApplication No.Company
ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET;ORALOver-the-counterYes020872SANOFI AVENTIS US
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET;ORALOver-the-counterNo202039AUROLIFE PHARMA LLC
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET;ORALOver-the-counterNo076502DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET;ORALOver-the-counterNo211075GRANULES
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET;ORALOver-the-counterNo204097HETERO LABS LTD V
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET;ORALOver-the-counterNo077081MYLAN
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET;ORALOver-the-counterNo204507SCIEGEN PHARMS INC
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET;ORALOver-the-counterNo091567SUN PHARM INDS
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET;ORALOver-the-counterNo076447TEVA
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET;ORALOver-the-counterNo079112WOCKHARDT LTD
FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET;ORALOver-the-counterNo076502DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET;ORALOver-the-counterNo077081MYLAN
FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET;ORALOver-the-counterNo204507SCIEGEN PHARMS INC
FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET;ORALOver-the-counterNo091567SUN PHARM INDS
FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET;ORALOver-the-counterNo076447TEVA
FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET;ORALOver-the-counterNo079112WOCKHARDT 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 NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDApplication No.Company
ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALOver-the-counterYes020872SANOFI AVENTIS US
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALOver-the-counterNo202039AUROLIFE PHARMA LLC
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALOver-the-counterNo076502DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALOver-the-counterNo211075GRANULES
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALOver-the-counterNo204097HETERO LABS LTD V
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALOver-the-counterNo077081MYLAN
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALOver-the-counterNo204507SCIEGEN PHARMS INC
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALOver-the-counterNo091567SUN PHARM INDS
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALOver-the-counterNo076447TEVA
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALOver-the-counterNo210137UNIQUE PHARM LABS
FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALOver-the-counterNo079112WOCKHARDT LTD
FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALOver-the-counterNo076502DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALOver-the-counterNo077081MYLAN
FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALOver-the-counterNo204507SCIEGEN PHARMS INC
FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALOver-the-counterNo091567SUN PHARM INDS
FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALOver-the-counterNo076447TEVA
FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET;ORALOver-the-counterNo079112WOCKHARDT 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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