Details for New Drug Application (NDA): 021748

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NDA 021748 describes GLUMETZA, which is a drug marketed by Santarus Inc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the GLUMETZA profile page.

The generic ingredient in GLUMETZA is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-eight suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

Summary for 021748

Tradename:	GLUMETZA
Applicant:	Santarus Inc
Ingredient:	metformin hydrochloride
Patents:	1

Pharmacology for NDA: 021748

Medical Subject Heading (MeSH) Categories for 021748

Hypoglycemic Agents

Suppliers and Packaging for NDA: 021748

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748	NDA	Santarus, Inc.	68012-002	68012-002-13	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-002-13)
GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748	NDA	Santarus, Inc.	68012-003	68012-003-16	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-003-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	500MG
Approval Date:	Jun 3, 2005	TE:	AB3	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1GM
Approval Date:	Jun 3, 2005	TE:	AB3	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Mar 23, 2025	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 021748

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	⤷ Sign Up	⤷ Sign Up
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005	⤷ Sign Up	⤷ Sign Up
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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