Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020682
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLYSET MIGLITOL 25MG TABLET;ORAL Prescription AB Yes Yes
GLYSET MIGLITOL 50MG TABLET;ORAL Prescription AB Yes No
GLYSET MIGLITOL 100MG TABLET;ORAL Prescription AB 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
12/18/1996 ORIG-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/pre96/020682orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/14/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/17/2012 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020682s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020682Orig1s010ltr.pdf
04/24/2009 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020682s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020682s008ltr.pdf
09/29/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/23/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/06/1999 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/16/1999 SUPPL-1 Efficacy-Labeling Change With Clinical Data Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020682S001_Glyset_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020682S001_Glyset.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/17/2012 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020682s010lbl.pdf
04/24/2009 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020682s008lbl.pdf

GLYSET

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYSET MIGLITOL 25MG TABLET;ORAL Prescription Yes AB 020682 PHARMACIA AND UPJOHN
MIGLITOL MIGLITOL 25MG TABLET;ORAL Prescription No AB 203965 ORIENT PHARMA CO LTD

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYSET MIGLITOL 50MG TABLET;ORAL Prescription Yes AB 020682 PHARMACIA AND UPJOHN
MIGLITOL MIGLITOL 50MG TABLET;ORAL Prescription No AB 203965 ORIENT PHARMA CO LTD

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYSET MIGLITOL 100MG TABLET;ORAL Prescription Yes AB 020682 PHARMACIA AND UPJOHN
MIGLITOL MIGLITOL 100MG TABLET;ORAL Prescription No AB 203965 ORIENT PHARMA CO LTD

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English