Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017118
Company: ENDO PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYMMETREL AMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP; 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
07/20/1976 ORIG-1 Approval Type 6 - New Indication (no longer used) 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
12/31/2008 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017118s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017118s019ltr.pdf
09/04/2003 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17118slr017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017118_s017_Symmetrel_syrup.pdf
01/11/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1999 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/31/1999 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/11/1996 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1986 SUPPL-7 Labeling

Label is not available on this site.

10/27/1978 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/02/1977 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/31/2008 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017118s019lbl.pdf
09/04/2003 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018101s009lbl.pdf

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