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Generated: August 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020357

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NDA 020357 describes GLUCOPHAGE, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the GLUCOPHAGE profile page.

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

Summary for NDA: 020357

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 020357

Ingredient-typeBiguanides

Suppliers and Packaging for NDA: 020357

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLUCOPHAGE
metformin hydrochloride
TABLET;ORAL 020357 NDA Bristol-Myers Squibb Company 0087-6060 0087-6060-05 100 TABLET, FILM COATED in 1 BOTTLE (0087-6060-05)
GLUCOPHAGE
metformin hydrochloride
TABLET;ORAL 020357 NDA Bristol-Myers Squibb Company 0087-6060 0087-6060-10 500 TABLET, FILM COATED in 1 BOTTLE (0087-6060-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Mar 3, 1995TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength850MG
Approval Date:Mar 3, 1995TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength625MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 5, 1998TE:RLD:Yes


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Serving 500+ biopharmaceutical companies globally:

Baxter
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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