Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021793
Company: MEDA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REGLAN ODT METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None No No
REGLAN ODT METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None No 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
06/10/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021793lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021793ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021793s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/30/2011 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021793s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021793s011ltr.pdf
08/02/2011 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021793s009ltr.pdf
11/18/2010 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021793s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017854s055,021793s008ltr.pdf
09/09/2010 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021793s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021793s007ltr.pdf
09/04/2009 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017854s052_021793s005ltr.pdf
06/30/2009 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s051,021793s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017854s051,021793s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021793_s004a_reglan tablets.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/30/2011 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021793s011lbl.pdf
11/18/2010 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021793s008lbl.pdf
09/09/2010 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021793s007lbl.pdf
06/30/2009 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s051,021793s004lbl.pdf
06/10/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021793lbl.pdf

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