Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020051
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLYNASE GLYBURIDE 1.5MG TABLET;ORAL Prescription AB Yes No
GLYNASE GLYBURIDE 3MG TABLET;ORAL Prescription AB Yes No
GLYNASE GLYBURIDE 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
GLYNASE GLYBURIDE 6MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/04/1992 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/22/2017 SUPPL-22 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020051s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020051Orig1s022ltr.pdf
05/22/2015 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020051s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020051Orig1s021ltr.pdf
10/15/2013 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020051s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020051Orig1s020ltr.pdf
02/07/2011 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020051s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020051s017ltr.pdf
08/27/2009 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020051s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020051s016ltr.pdf
10/29/2008 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020051s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020051s013ltr.pdf
11/30/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/28/1999 SUPPL-9 Labeling

Label is not available on this site.

01/10/1997 SUPPL-8 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020051S003ap.pdf
04/18/1997 SUPPL-7 Labeling

Label is not available on this site.

02/21/1996 SUPPL-4 Labeling

Label is not available on this site.

01/21/1993 SUPPL-3 Labeling

Label is not available on this site.

09/24/1993 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/22/2017 SUPPL-22 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020051s022lbl.pdf
08/22/2017 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020051s022lbl.pdf
05/22/2015 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020051s021lbl.pdf
10/15/2013 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020051s020lbl.pdf
02/07/2011 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020051s017lbl.pdf
08/27/2009 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020051s016lbl.pdf
10/29/2008 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020051s013lbl.pdf

GLYNASE

TABLET;ORAL; 1.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYBURIDE (MICRONIZED) GLYBURIDE 1.5MG TABLET;ORAL Prescription No AB 074591 DAVA PHARMS INC
GLYBURIDE (MICRONIZED) GLYBURIDE 1.5MG TABLET;ORAL Prescription No AB 075890 HIKMA
GLYBURIDE (MICRONIZED) GLYBURIDE 1.5MG TABLET;ORAL Prescription No AB 074792 MYLAN
GLYBURIDE (MICRONIZED) GLYBURIDE 1.5MG TABLET;ORAL Prescription No AB 074686 TEVA
GLYNASE GLYBURIDE 1.5MG TABLET;ORAL Prescription Yes AB 020051 PHARMACIA AND UPJOHN

TABLET;ORAL; 3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYBURIDE (MICRONIZED) GLYBURIDE 3MG TABLET;ORAL Prescription No AB 074591 DAVA PHARMS INC
GLYBURIDE (MICRONIZED) GLYBURIDE 3MG TABLET;ORAL Prescription No AB 075890 HIKMA
GLYBURIDE (MICRONIZED) GLYBURIDE 3MG TABLET;ORAL Prescription No AB 074792 MYLAN
GLYBURIDE (MICRONIZED) GLYBURIDE 3MG TABLET;ORAL Prescription No AB 074686 TEVA
GLYNASE GLYBURIDE 3MG TABLET;ORAL Prescription Yes AB 020051 PHARMACIA AND UPJOHN

TABLET;ORAL; 6MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYBURIDE (MICRONIZED) GLYBURIDE 6MG TABLET;ORAL Prescription No AB 074591 DAVA PHARMS INC
GLYBURIDE (MICRONIZED) GLYBURIDE 6MG TABLET;ORAL Prescription No AB 075890 HIKMA
GLYBURIDE (MICRONIZED) GLYBURIDE 6MG TABLET;ORAL Prescription No AB 074792 MYLAN
GLYBURIDE (MICRONIZED) GLYBURIDE 6MG TABLET;ORAL Prescription No AB 074686 TEVA
GLYNASE GLYBURIDE 6MG TABLET;ORAL Prescription Yes AB 020051 PHARMACIA AND UPJOHN

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