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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021574
Company: ANDRX LABS LLC

Products on NDA 021574

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FORTAMET	METFORMIN HYDROCHLORIDE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
FORTAMET	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021574

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/27/2004	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21574_fortamet_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21574ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021574s000_ForametTOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2017	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021574s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021574Orig1s020ltr.pdf
05/18/2015	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
11/08/2018	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021574s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021574Orig1s017ltr.pdf
07/29/2008	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021574s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021574s010ltr.pdf
04/19/2007	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021574s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021574s006)_LTR.pdf
02/08/2006	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021574s005ltr.pdf

Labels for NDA 021574

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/08/2018	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021574s017lbl.pdf
04/05/2017	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021574s020lbl.pdf
07/29/2008	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021574s010lbl.pdf
04/19/2007	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021574s006lbl.pdf
04/27/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21574_fortamet_lbl.pdf

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