01 1APOTEX
02 1APOTEX INC
03 1BAUSCH
04 2CHARTWELL MOLECULES
05 2COSETTE
06 1DASH PHARMS NATCO
07 1G AND W LABS INC
08 1KENTON
09 1LANNETT CO INC
10 1MLV
11 2NORVIUM BIOSCIENCE
12 1NOVITIUM PHARMA
13 1RISING
14 6SOMERSET
01 5CAPSULE;ORAL
02 3FILM, EXTENDED RELEASE;TRANSDERMAL
03 3SYSTEM; TRANSDERMAL
04 1TABLET, ORALLY DISINTEGRATING;ORAL
05 10TABLET;ORAL
01 10DISCN
02 9RX
03 3Blank
01 1ELDEPRYL
02 6EMSAM
03 14SELEGILINE HYDROCHLORIDE
04 1ZELAPAR
01 13No
02 6Yes
03 3Blank
RLD : Yes
TE Code :
Brand Name : ZELAPAR
Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL
Dosage Strength : 1.25MG
Approval Date : 2006-06-14
Application Number : 21479
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : SELEGILINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Approval Date : 1996-08-02
Application Number : 74537
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : EMSAM
Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL
Dosage Strength : 6MG/24HR
Approval Date : 2006-02-27
Application Number : 21336
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : EMSAM
Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL
Dosage Strength : 9MG/24HR
Approval Date : 2006-02-27
Application Number : 21336
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : EMSAM
Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL
Dosage Strength : 12MG/24HR
Approval Date : 2006-02-27
Application Number : 21336
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD :
TE Code :
Brand Name : EMSAM
Dosage Form : SYSTEM; TRANSDERMAL
Dosage Strength : 6MG
Approval Date :
Application Number : 21708
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : EMSAM
Dosage Form : SYSTEM; TRANSDERMAL
Dosage Strength : 9MG
Approval Date :
Application Number : 21708
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : EMSAM
Dosage Form : SYSTEM; TRANSDERMAL
Dosage Strength : 12MG
Approval Date :
Application Number : 21708
RX/OTC/DISCN :
RLD :
TE Code :
Brand Name : SELEGILINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1989-06-05
Application Number : 19334
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Brand Name : ELDEPRYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1996-05-15
Application Number : 20647
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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