Details for New Drug Application (NDA): 203965

NDA 203965 describes MIGLITOL, which is a drug marketed by Westminster Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the MIGLITOL profile page.

The generic ingredient in MIGLITOL is miglitol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the miglitol profile page.

Summary for 203965

Tradename:	MIGLITOL
Applicant:	Westminster Pharms
Ingredient:	miglitol
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 203965

Mechanism of Action

alpha Glucosidase Inhibitors

Suppliers and Packaging for NDA: 203965

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MIGLITOL	miglitol	TABLET;ORAL	203965	ANDA	Westminster Pharmaceuticals, LLC	69367-303	69367-303-01	100 TABLET, COATED in 1 BOTTLE (69367-303-01)
MIGLITOL	miglitol	TABLET;ORAL	203965	ANDA	Westminster Pharmaceuticals, LLC	69367-304	69367-304-01	100 TABLET, COATED in 1 BOTTLE (69367-304-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Feb 24, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Feb 24, 2015	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Feb 24, 2015	TE:	AB	RLD:	No

Complete Access Available with Subscription