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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020682
Company: PFIZER

Products on NDA 020682

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020682

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

Labels for NDA 020682

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

Therapeutic Equivalents for NDA 020682

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	PFIZER
MIGLITOL	MIGLITOL	25MG	TABLET;ORAL	Prescription	No	AB	203965	WESTMINSTER PHARMS

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	PFIZER
MIGLITOL	MIGLITOL	50MG	TABLET;ORAL	Prescription	No	AB	203965	WESTMINSTER PHARMS

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	PFIZER
MIGLITOL	MIGLITOL	100MG	TABLET;ORAL	Prescription	No	AB	203965	WESTMINSTER PHARMS

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