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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020051
Company: PFIZER

Products on NDA 020051

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GLYNASE	GLYBURIDE	4.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
GLYNASE	GLYBURIDE	6MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020051

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.

Labels for NDA 020051

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

Therapeutic Equivalents for NDA 020051

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	074686	TEVA
GLYNASE	GLYBURIDE	1.5MG	TABLET;ORAL	Prescription	Yes	AB	020051	PFIZER

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	074686	TEVA
GLYNASE	GLYBURIDE	3MG	TABLET;ORAL	Prescription	Yes	AB	020051	PFIZER

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	074686	TEVA
GLYNASE	GLYBURIDE	6MG	TABLET;ORAL	Prescription	Yes	AB	020051	PFIZER

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