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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021202


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NDA 021202 describes GLUCOPHAGE XR, which is a drug marketed by Emd Serono Inc and is included in one NDA. It is available from one supplier. Additional details are available on the GLUCOPHAGE XR profile page.

The generic ingredient in GLUCOPHAGE XR is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-five suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
Summary for 021202
Tradename:GLUCOPHAGE XR
Applicant:Emd Serono Inc
Ingredient:metformin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021202
Medical Subject Heading (MeSH) Categories for 021202
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)
Paragraph IV (Patent) Challenges for 021202
Tradename Dosage Ingredient NDA Submissiondate
GLUCOPHAGE XR TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride 021202

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 13, 2000TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 11, 2003TE:RLD:Yes

Expired US Patents for NDA 021202

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono Inc GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-001 Oct 13, 2000   Start Trial   Start Trial
Emd Serono Inc GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-004 Apr 11, 2003   Start Trial   Start Trial
Emd Serono Inc GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-004 Apr 11, 2003   Start Trial   Start Trial
Emd Serono Inc GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-001 Oct 13, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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