Orange Book product · Brand (NDA)
TENSILON PRESERVATIVE FREE
EDROPHONIUM CHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
EDROPHONIUM CHLORIDE
Strength
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 007959
Product number
002
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.
- 1998EDROPHONIUM CHLORIDEGeneric (ANDA)
ANDA 040131 · HOSPIRA
- 1996EDROPHONIUM CHLORIDEGeneric (ANDA)
ANDA 040044 · WATSON LABS
- 1996EDROPHONIUM CHLORIDE PRESERVATIVE FREEGeneric (ANDA)
ANDA 040043 · WATSON LABS
- 1988REVERSOLGeneric (ANDA)
ANDA 089624 · ORGANON USA INC
- 1985ENLONGeneric (ANDA)
ANDA 088873 · PHARMOBEDIENT
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.
