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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021748
Company: SANTARUS INC

Products on NDA 021748

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021748

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-Package Insert, Labeling-Patient 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-Package Insert, Labeling-Container/Carton Labels		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

Labels for NDA 021748

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/07/2018	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021748s025lbl.pdf
11/07/2018	SUPPL-25	Labeling-Patient 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

Therapeutic Equivalents for NDA 021748

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	213962	AJANTA PHARMA LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	213356	APOTEX
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	212969	GLENMARK PHARMS LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	213344	GRANULES
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	212448	MICRO LABS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	212681	PRINSTON INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	215629	RK PHARMA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	213334	SCIEGEN PHARMS INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	202917	SUN PHARM

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	213962	AJANTA PHARMA LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	213356	APOTEX
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	212969	GLENMARK PHARMS LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	213344	GRANULES
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	211163	MACLEODS PHARMS LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	212448	MICRO LABS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	212681	PRINSTON INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	215629	RK PHARMA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	213334	SCIEGEN PHARMS INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	202917	SUN PHARM

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