Orange Book product · Brand (NDA)
ELDEPRYL
SELEGILINE HYDROCHLORIDE
At a glance
May 15, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 15, 1996
30 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
SELEGILINE HYDROCHLORIDE
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 020647
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2006ZELAPARBrand (NDA)
NDA 021479 · BAUSCH
- 1989SELEGILINE HYDROCHLORIDEBrand (NDA)
NDA 019334 · QUAGEN
- 2019SELEGILINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206803 · RISING
- 2003SELEGILINE HYDROCHLORIDEGeneric (ANDA)
ANDA 075145 · LANNETT CO INC
- 1998SELEGILINE HYDROCHLORIDEGeneric (ANDA)
ANDA 075321 · APOTEX
- 1998SELEGILINE HYDROCHLORIDEGeneric (ANDA)
ANDA 075352 · NOVITIUM PHARMA
- 1998SELEGILINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074756 · COSETTE
- 1998SELEGILINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074912 · KENTON
- 1997SELEGILINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074866 · NOVITIUM PHARMA
- 1997SELEGILINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074871 · APOTEX
- 1997SELEGILINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074672 · I3 PHARMS
- 1997SELEGILINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074744 · COSETTE
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
