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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. There are three patents protecting this drug. Additional details are available on the EMSAM profile page.

The generic ingredient in EMSAM is selegiline. There are fifteen 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 NDA: 021336

Tradename:
EMSAM
Applicant:
Somerset
Ingredient:
selegiline
Patents:3
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 021336

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 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 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength6MG/24HR
Approval Date:Feb 27, 2006TE:RLD:Yes
Patent:7,070,808Patent Expiration:May 10, 2018Product Flag?YSubstance Flag?YDelist Request?
Patent:7,150,881Patent Expiration:Jun 12, 2018Product Flag?YSubstance Flag?YDelist Request?
Patent:7,638,140Patent Expiration:May 10, 2018Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021336

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Somerset
EMSAM
selegiline
FILM, EXTENDED RELEASE;TRANSDERMAL021336-001Feb 27, 2006RE34579► subscribe
Somerset
EMSAM
selegiline
FILM, EXTENDED RELEASE;TRANSDERMAL021336-003Feb 27, 2006RE34579► subscribe
Somerset
EMSAM
selegiline
FILM, EXTENDED RELEASE;TRANSDERMAL021336-002Feb 27, 2006RE34579► subscribe
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