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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020647
Company: SOMERSET

Products on NDA 020647

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELDEPRYL	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020647

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/15/1996	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/20/2013	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/31/2008	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020647s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020647s006,020647s007ltr.pdf
12/31/2008	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020647s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020647s006,020647s007ltr.pdf
02/15/2001	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
08/06/1997	SUPPL-3	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020647a_s01_s02_s03.pdf

Labels for NDA 020647

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/31/2008	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020647s006s007lbl.pdf
12/31/2008	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020647s006s007lbl.pdf

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