Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021574
Company: ANDRX LABS LLC
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FORTAMET METFORMIN HYDROCHLORIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
FORTAMET METFORMIN HYDROCHLORIDE 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
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.cfm
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
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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