Details for New Drug Application (NDA): 021336
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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
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Somerset | EMSAM | selegiline | FILM, EXTENDED RELEASE;TRANSDERMAL | 021336-001 | Feb 27, 2006 | ⤷ Sign Up | ⤷ Sign Up |
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 | 021336-003 | Feb 27, 2006 | ⤷ Sign Up | ⤷ Sign Up |
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