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.
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 | 021336-003 | Feb 27, 2006 | ⤷ Subscribe | ⤷ Subscribe |
| Somerset | EMSAM | selegiline | FILM, EXTENDED RELEASE;TRANSDERMAL | 021336-002 | Feb 27, 2006 | ⤷ Subscribe | ⤷ Subscribe |
| Somerset | EMSAM | selegiline | FILM, EXTENDED RELEASE;TRANSDERMAL | 021336-003 | Feb 27, 2006 | ⤷ Subscribe | ⤷ Subscribe |
| Somerset | EMSAM | selegiline | FILM, EXTENDED RELEASE;TRANSDERMAL | 021336-001 | Feb 27, 2006 | ⤷ Subscribe | ⤷ Subscribe |
| Somerset | EMSAM | selegiline | FILM, EXTENDED RELEASE;TRANSDERMAL | 021336-002 | Feb 27, 2006 | ⤷ Subscribe | ⤷ Subscribe |
| Somerset | EMSAM | selegiline | FILM, EXTENDED RELEASE;TRANSDERMAL | 021336-003 | Feb 27, 2006 | ⤷ Subscribe | ⤷ Subscribe |
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