Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021336

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EMSAM (SELEGILINE)
6MG/24HR
Marketing Status: Prescription

Active Ingredient: SELEGILINE
Proprietary Name: EMSAM
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 6MG/24HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021336
Product Number: 001
Approval Date: Feb 27, 2006
Applicant Holder Full Name: SOMERSET PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

EMSAM (SELEGILINE)
9MG/24HR
Marketing Status: Prescription

Active Ingredient: SELEGILINE
Proprietary Name: EMSAM
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 9MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021336
Product Number: 002
Approval Date: Feb 27, 2006
Applicant Holder Full Name: SOMERSET PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

EMSAM (SELEGILINE)
12MG/24HR
Marketing Status: Prescription

Active Ingredient: SELEGILINE
Proprietary Name: EMSAM
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 12MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021336
Product Number: 003
Approval Date: Feb 27, 2006
Applicant Holder Full Name: SOMERSET PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information