Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021202
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLUCOPHAGE XR METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription AB1 Yes No
GLUCOPHAGE XR METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/13/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21202lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21202ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-202_Glucophage.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/05/2017 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020357Orig1s037s039,021202Orig1s021s023ltr.pdf
04/05/2017 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020357Orig1s037s039,021202Orig1s021s023ltr.pdf
03/05/2014 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/31/2014 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/30/2018 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020357s034,021202s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020357Orig1s034, 021202Orig1s018ltr.pdf
08/27/2008 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020357s031,021202s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020357s031, 021202s016ltr.pdf
11/01/2006 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020357s030,021202s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020357s030,021202s015ltr.pdf
03/19/2004 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20357slr026,027,21202slr011,013ltr.pdf
03/19/2004 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20357slr026,027,21202slr011,013ltr.pdf
04/11/2003 SUPPL-8 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21202scf008_glucophage_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21202scs008ltr.pdf
06/06/2002 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/02/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/08/2002 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/08/2002 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21202s3ltr.pdf
07/31/2001 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/19/2001 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21202S1ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/30/2018 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020357s034,021202s018lbl.pdf
04/05/2017 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf
04/05/2017 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf
08/27/2008 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020357s031,021202s016lbl.pdf
11/01/2006 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020357s030,021202s015lbl.pdf
04/11/2003 SUPPL-8 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21202scf008_glucophage_lbl.pdf
10/13/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21202lbl.pdf

GLUCOPHAGE XR

TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLUCOPHAGE XR METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB1 021202 BRISTOL MYERS SQUIBB
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 076172 ACTAVIS LABS FL INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 209303 ALIGNSCIENCE PHARMA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 206145 ALKEM LABS LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 078596 AMNEAL PHARMS NY
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 076706 APOTEX
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 079118 AUROBINDO PHARMA LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 207427 BEXIMCO PHARMS USA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 077060 CADILA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 078321 CSPC OUYI
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 209313 GRANULES INDIA LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 202306 INTELLIPHARMACEUTICS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 201991 INVENTIA HLTHCARE
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 206955 MACLEODS PHARMS LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 090295 MARKSANS PHARMA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 076756 NOSTRUM PHARMS LLC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 208880 PRINSTON INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 076873 SANDOZ
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 077336 SUN PHARM INDS (IN)
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 076269 TEVA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 090014 TORRENT
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 211052 YICHANG HUMANWELL

TABLET, EXTENDED RELEASE;ORAL; 750MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLUCOPHAGE XR METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021202 BRISTOL MYERS SQUIBB
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076869 ACTAVIS LABS FL INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206145 ALKEM LABS LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078596 AMNEAL PHARMS NY
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076706 APOTEX
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079118 AUROBINDO PHARMA LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076863 BARR
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207427 BEXIMCO PHARMS USA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077078 CADILA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078321 CSPC OUYI
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209313 GRANULES INDIA LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202306 INTELLIPHARMACEUTICS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206955 MACLEODS PHARMS LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090295 MARKSANS PHARMA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076756 NOSTRUM PHARMS LLC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208880 PRINSTON INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077336 SUN PHARM INDS (IN)
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076864 TEVA
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 750MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211052 YICHANG HUMANWELL

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