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Details for New Drug Application (NDA): 021202

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NDA 021202 describes GLUCOPHAGE XR, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the GLUCOPHAGE XR profile page.

The generic ingredient in GLUCOPHAGE XR is metformin hydrochloride. There are forty-seven drug master file entries for this compound. Eighty-eight suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the metformin hydrochloride profile page.

Summary for NDA: 021202

Tradename:
GLUCOPHAGE XR
Applicant:
Bristol Myers Squibb
Ingredient:
metformin hydrochloride
Patents:2
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 021202

Ingredient-typeBiguanides

Suppliers and Packaging for NDA: 021202

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLUCOPHAGE XR
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 021202 NDA Bristol-Myers Squibb Company 0087-6063 0087-6063-13 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0087-6063-13)
GLUCOPHAGE XR
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 021202 NDA Bristol-Myers Squibb Company 0087-6064 0087-6064-13 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0087-6064-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Oct 13, 2000TE:AB1RLD:No
Patent:6,475,521Patent Expiration:Mar 19, 2018Product Flag?Substance Flag?Delist Request?
Patent:6,660,300Patent Expiration:Mar 19, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING PATIENT WITH TYPE 2 DIABETES BY ONCE DAILY ADMINISTRATION

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Apr 11, 2003TE:ABRLD:Yes
Patent:6,475,521Patent Expiration:Mar 19, 2018Product Flag?Substance Flag?Delist Request?


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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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