Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021627
Company: ALLERGAN SALES LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAMENDA MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION;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
04/18/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021627lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021627ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021627s000_NamendaTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/11/2014 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021627s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021627Orig1s012ltr.pdf
07/10/2014 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/24/2013 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf
04/19/2006 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s007, 021627s002LTR.pdf
10/04/2006 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s008,021627s001LTR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/11/2014 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021627s012lbl.pdf
10/24/2013 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf
04/18/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021627lbl.pdf

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