Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016023
Company: ENDO PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYMMETREL AMANTADINE HYDROCHLORIDE 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP;ORAL Discontinued None Yes No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
02/14/1968 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/02/2009 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016023s041,018101s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016023s041,018101s016ltr.pdf
09/24/2008 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016023s040,018101s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016023s040, 018101s015ltr.pdf
03/02/2007 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016023s039,018101s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016023s039, 018101s014.pdf
11/18/2003 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18101slr009,16023slr037ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/016023s037_018101s009_SymmetrelTOC.cfm
01/11/2002 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/2000 SUPPL-35 Labeling

Label is not available on this site.

06/08/1999 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/05/1996 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

08/11/1992 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

02/04/1992 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

02/06/1992 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/23/1989 SUPPL-24 Labeling

Label is not available on this site.

04/19/1993 SUPPL-23 Efficacy-New Dosing Regimen

Label is not available on this site.

01/16/1987 SUPPL-22 Efficacy-New Indication

Label is not available on this site.

02/14/1986 SUPPL-21 Labeling

Label is not available on this site.

01/04/1985 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/08/1982 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/10/1977 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/16/1977 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/07/1976 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/02/2009 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016023s041,018101s016lbl.pdf
09/24/2008 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016023s040,018101s015lbl.pdf
03/02/2007 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016023s039,018101s014lbl.pdf
11/18/2003 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf

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