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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019334
Company: SOMERSET

Products on NDA 019334

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HYDROCHLORIDE	SELEGILINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019334

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/1989	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan		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-20	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019334s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019334s020,019334s019ltr.pdf
12/31/2008	SUPPL-19	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019334s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019334s020,019334s019ltr.pdf
08/06/1997	SUPPL-17	Labeling		Label is not available on this site.
07/13/1994	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
02/12/1993	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
01/05/1993	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/05/1993	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
01/05/1993	SUPPL-7	Labeling		Label is not available on this site.
01/05/1993	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
01/05/1993	SUPPL-5	Labeling		Label is not available on this site.
07/25/1990	SUPPL-3	Labeling		Label is not available on this site.
03/01/1990	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/26/1990	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 019334

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/31/2008	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019334s019s020lbl.pdf
12/31/2008	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019334s019s020lbl.pdf

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