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Mallinckrodt
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US Army
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Generated: April 23, 2018

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 two 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-eight drug master file entries for this compound. Ninety-seven 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
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 021748
Ingredient-typeBiguanides
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 Santarus, Inc. 68012-002 N 68012-002-13
GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748 NDA Santarus, Inc. 68012-002 N 68012-002-92

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jun 3, 2005TE:AB3RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jun 20, 2020Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent 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:➤ Try a Free TrialPatent Expiration:Jun 20, 2020Product 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 021748-001 Jun 3, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Citi
US Army
Merck
QuintilesIMS
Cipla
McKinsey
Queensland Health
Federal Trade Commission

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