Details for New Drug Application (NDA): 021336

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NDA 021336 describes EMSAM, which is a drug marketed by Somerset and is included in one NDA. It is available from one supplier. Additional details are available on the EMSAM profile page.

The generic ingredient in EMSAM is selegiline. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the selegiline profile page.

Summary for 021336

Tradename:	EMSAM
Applicant:	Somerset
Ingredient:	selegiline
Patents:	0

Pharmacology for NDA: 021336

Mechanism of Action	Monoamine Oxidase Inhibitors Monoamine Oxidase-B Inhibitors

Medical Subject Heading (MeSH) Categories for 021336

Antiparkinson Agents
Monoamine Oxidase Inhibitors
Neuroprotective Agents

Suppliers and Packaging for NDA: 021336

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EMSAM	selegiline	FILM, EXTENDED RELEASE;TRANSDERMAL	021336	NDA	Mylan Specialty L.P.	49502-900	49502-900-05	5 POUCH in 1 CARTON (49502-900-05) / 1 PATCH in 1 POUCH (49502-900-11) / 24 h in 1 PATCH
EMSAM	selegiline	FILM, EXTENDED RELEASE;TRANSDERMAL	021336	NDA	Mylan Specialty L.P.	49502-900	49502-900-30	30 POUCH in 1 CARTON (49502-900-30) / 1 PATCH in 1 POUCH (49502-900-01) / 24 h in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	6MG/24HR
Approval Date:	Feb 27, 2006	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	9MG/24HR
Approval Date:	Feb 27, 2006	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	12MG/24HR
Approval Date:	Feb 27, 2006	TE:		RLD:	Yes

Expired US Patents for NDA 021336

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Somerset	EMSAM	selegiline	FILM, EXTENDED RELEASE;TRANSDERMAL	021336-003	Feb 27, 2006	⤷ Sign Up	⤷ Sign Up
Somerset	EMSAM	selegiline	FILM, EXTENDED RELEASE;TRANSDERMAL	021336-001	Feb 27, 2006	⤷ Sign Up	⤷ Sign Up
Somerset	EMSAM	selegiline	FILM, EXTENDED RELEASE;TRANSDERMAL	021336-001	Feb 27, 2006	⤷ Sign Up	⤷ Sign Up
Somerset	EMSAM	selegiline	FILM, EXTENDED RELEASE;TRANSDERMAL	021336-002	Feb 27, 2006	⤷ Sign Up	⤷ Sign Up
Somerset	EMSAM	selegiline	FILM, EXTENDED RELEASE;TRANSDERMAL	021336-002	Feb 27, 2006	⤷ Sign Up	⤷ Sign Up
Somerset	EMSAM	selegiline	FILM, EXTENDED RELEASE;TRANSDERMAL	021336-002	Feb 27, 2006	⤷ Sign Up	⤷ Sign Up
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