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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017118
Company: ENDO PHARMS

Products on NDA 017118

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017118

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.

Labels for NDA 017118

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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