AMARYL از شرکت SANOFI AVENTIS US

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داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

AMARYL از شرکت SANOFI AVENTIS US

New Drug Application (NDA): 020496

Company: SANOFI AVENTIS US

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
AMARYLGLIMEPIRIDE1MGTABLET;ORALPrescription

AB

YesYes
AMARYLGLIMEPIRIDE2MGTABLET;ORALPrescription

AB

YesNo
AMARYLGLIMEPIRIDE4MGTABLET;ORALPrescription

AB

YesNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
11/30/1995ORIG-1 Approval

Type 1 – New Molecular Entity

STANDARD

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020496Orig1s000rev.pdf

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
12/21/2018SUPPL-29 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020496s029lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020496Orig1s029Ltr.pdf

12/19/2016SUPPL-28 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020496s028lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020496Orig1s028ltr.pdf

10/15/2013SUPPL-27 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s027lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020496Orig1s027ltr.pdf

08/01/2013SUPPL-26 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s026lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020496Orig1s026ltr.pdf

04/19/2013SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/14/2013SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/03/2012SUPPL-22 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020496s022lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020496s022ltr.pdf

06/04/2009SUPPL-21 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s021lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s021ltr.pdf

02/03/2009SUPPL-19 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s018, s019ltr.pdf

02/03/2009SUPPL-18 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s018, s019ltr.pdf

09/19/2005SUPPL-16 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s016lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020496s016ltr.pdf

11/28/2005SUPPL-15 Efficacy-New Patient Population

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s015lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020496s015ltr.pdf

08/16/2004SUPPL-13 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20496s013ltr.pdf

07/21/2001SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/05/2000SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/2000SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/2002SUPPL-7 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20496s7ltr.pdf

01/06/2000SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/27/2000SUPPL-5 Efficacy-Labeling Change With Clinical Data

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20496-S005_Amaryl.pdf

09/16/1998SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/16/1998SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/24/1999SUPPL-2 Efficacy-New Indication

Letter (PDF)

Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20496s2ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020496S002.cfm

07/28/1997SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
12/21/2018SUPPL-29

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020496s029lbl.pdf
12/19/2016SUPPL-28

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020496s028lbl.pdf
10/15/2013SUPPL-27

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s027lbl.pdf
08/01/2013SUPPL-26

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s026lbl.pdf
02/03/2012SUPPL-22

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020496s022lbl.pdf
06/04/2009SUPPL-21

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s021lbl.pdf
02/03/2009SUPPL-19

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf
02/03/2009SUPPL-18

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf
11/28/2005SUPPL-15

Efficacy-New Patient Population

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s015lbl.pdf
09/19/2005SUPPL-16

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s016lbl.pdf

AMARYL

TABLET;ORAL; 1MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
AMARYLGLIMEPIRIDE1MGTABLET;ORALPrescriptionYesAB020496SANOFI AVENTIS US
GLIMEPIRIDEGLIMEPIRIDE1MGTABLET;ORALPrescriptionNoAB078181ACCORD HLTHCARE
GLIMEPIRIDEGLIMEPIRIDE1MGTABLET;ORALPrescriptionNoAB202759AUROBINDO PHARMA LTD
GLIMEPIRIDEGLIMEPIRIDE1MGTABLET;ORALPrescriptionNoAB077911CARLSBAD
GLIMEPIRIDEGLIMEPIRIDE1MGTABLET;ORALPrescriptionNoAB077091DR REDDYS LABS LTD
GLIMEPIRIDEGLIMEPIRIDE1MGTABLET;ORALPrescriptionNoAB202112INDOCO REMEDIES
GLIMEPIRIDEGLIMEPIRIDE1MGTABLET;ORALPrescriptionNoAB077295INVAGEN PHARMS
GLIMEPIRIDEGLIMEPIRIDE1MGTABLET;ORALPrescriptionNoAB091220MICRO LABS
GLIMEPIRIDEGLIMEPIRIDE1MGTABLET;ORALPrescriptionNoAB077370PRINSTON INC

TABLET;ORAL; 2MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
AMARYLGLIMEPIRIDE2MGTABLET;ORALPrescriptionYesAB020496SANOFI AVENTIS US
GLIMEPIRIDEGLIMEPIRIDE2MGTABLET;ORALPrescriptionNoAB078181ACCORD HLTHCARE
GLIMEPIRIDEGLIMEPIRIDE2MGTABLET;ORALPrescriptionNoAB202759AUROBINDO PHARMA LTD
GLIMEPIRIDEGLIMEPIRIDE2MGTABLET;ORALPrescriptionNoAB077911CARLSBAD
GLIMEPIRIDEGLIMEPIRIDE2MGTABLET;ORALPrescriptionNoAB077091DR REDDYS LABS LTD
GLIMEPIRIDEGLIMEPIRIDE2MGTABLET;ORALPrescriptionNoAB202112INDOCO REMEDIES
GLIMEPIRIDEGLIMEPIRIDE2MGTABLET;ORALPrescriptionNoAB077295INVAGEN PHARMS
GLIMEPIRIDEGLIMEPIRIDE2MGTABLET;ORALPrescriptionNoAB091220MICRO LABS
GLIMEPIRIDEGLIMEPIRIDE2MGTABLET;ORALPrescriptionNoAB077370PRINSTON INC

TABLET;ORAL; 4MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
AMARYLGLIMEPIRIDE4MGTABLET;ORALPrescriptionYesAB020496SANOFI AVENTIS US
GLIMEPIRIDEGLIMEPIRIDE4MGTABLET;ORALPrescriptionNoAB078181ACCORD HLTHCARE
GLIMEPIRIDEGLIMEPIRIDE4MGTABLET;ORALPrescriptionNoAB202759AUROBINDO PHARMA LTD
GLIMEPIRIDEGLIMEPIRIDE4MGTABLET;ORALPrescriptionNoAB077911CARLSBAD
GLIMEPIRIDEGLIMEPIRIDE4MGTABLET;ORALPrescriptionNoAB077091DR REDDYS LABS LTD
GLIMEPIRIDEGLIMEPIRIDE4MGTABLET;ORALPrescriptionNoAB202112INDOCO REMEDIES
GLIMEPIRIDEGLIMEPIRIDE4MGTABLET;ORALPrescriptionNoAB077295INVAGEN PHARMS
GLIMEPIRIDEGLIMEPIRIDE4MGTABLET;ORALPrescriptionNoAB091220MICRO LABS
GLIMEPIRIDEGLIMEPIRIDE4MGTABLET;ORALPrescriptionNoAB077370PRINSTON INC
بخوانید  BICALUTAMIDE از شرکت ACCORD HLTHCARE
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