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Generated: March 19, 2019

DrugPatentWatch Database Preview

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 three suppliers. There are four patents 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. One hundred and twelve 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:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 021748
Medical Subject Heading (MeSH) Categories for 021748
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 Depomed, Inc. 13913-002 13913-002-13 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (13913-002-13)
GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748 NDA Depomed, Inc. 13913-003 13913-003-16 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (13913-003-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jun 3, 2005TE:AB3RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 20, 2020Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Oct 25, 2021Product Flag?YSubstance Flag?YDelist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM
Approval Date:Jun 3, 2005TE:AB3RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 23, 2025Product Flag?YSubstance Flag?YDelist Request?

Expired US Patents for NDA 021748

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 021748-001 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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