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Generated: April 24, 2019

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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. 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. One hundred and fourteen suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
Summary for 021202
Tradename:GLUCOPHAGE XR
Applicant:Bristol Myers Squibb
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Oct 13, 2000TE:AB1RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Apr 11, 2003TE:ABRLD:Yes

Expired US Patents for NDA 021202

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-004 Apr 11, 2003 ➤ Sign Up ➤ Sign Up
Bristol Myers Squibb GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-004 Apr 11, 2003 ➤ Sign Up ➤ Sign Up
Bristol Myers Squibb GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-001 Oct 13, 2000 ➤ Sign Up ➤ Sign Up
Bristol Myers Squibb GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-001 Oct 13, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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