Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021748
Company: SANTARUS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLUMETZA METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription AB3 Yes No
GLUMETZA METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription AB3 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
06/03/2005 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021748lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021748ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021748s000_GlumetzaTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/07/2018 SUPPL-25 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021748s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021748Orig1s025ltr.pdf
04/05/2017 SUPPL-20 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021748s020lbl.pdf
10/27/2015 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/13/2011 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021748s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021748s010ltr.pdf
02/25/2010 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021748s008ltr.pdf
06/16/2009 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021748s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021748s005ltr.pdf
12/28/2007 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/01/2006 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021748s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021748s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/07/2018 SUPPL-25 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021748s025lbl.pdf
11/07/2018 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021748s025lbl.pdf
04/05/2017 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021748s020lbl.pdf
04/13/2011 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021748s010lbl.pdf
06/16/2009 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021748s005lbl.pdf
11/01/2006 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021748s002lbl.pdf
06/03/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021748lbl.pdf

GLUMETZA

TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLUMETZA METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB3 021748 SANTARUS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 203755 ACTAVIS LABS FL INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 091664 LUPIN LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 202917 SUN PHARMA GLOBAL

TABLET, EXTENDED RELEASE;ORAL; 1GM
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLUMETZA METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB3 021748 SANTARUS INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 203755 ACTAVIS LABS FL INC
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 091664 LUPIN LTD
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 202917 SUN PHARMA GLOBAL

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