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Last Updated: March 19, 2024

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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021336
Medical Subject Heading (MeSH) Categories for 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 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:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength6MG/24HR
Approval Date:Feb 27, 2006TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength9MG/24HR
Approval Date:Feb 27, 2006TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength12MG/24HR
Approval Date:Feb 27, 2006TE:RLD:Yes

Expired US Patents for NDA 021336

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

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