Orange Book product · Brand (NDA)
URECHOLINE
BETHANECHOL 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
BETHANECHOL CHLORIDE
Strength
5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 006536
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.
- 2010BETHANECHOL CHLORIDEGeneric (ANDA)
ANDA 091256 · HERITAGE PHARMA
- 2009BETHANECHOL CHLORIDEGeneric (ANDA)
ANDA 040897 · SUN PHARM INDS INC
- 2008BETHANECHOL CHLORIDEGeneric (ANDA)
ANDA 040677 · LANNETT CO INC
- 2007BETHANECHOL CHLORIDEGeneric (ANDA)
ANDA 040855 · AMNEAL PHARM
- 2007BETHANECHOL CHLORIDEGeneric (ANDA)
ANDA 040728 · CHARTWELL RX
- 2006BETHANECHOL CHLORIDEGeneric (ANDA)
ANDA 040721 · IMPAX LABS
- 2005BETHANECHOL CHLORIDEGeneric (ANDA)
ANDA 040633 · UPSHER SMITH LABS
- 2005BETHANECHOL CHLORIDEGeneric (ANDA)
ANDA 040634 · UPSHER SMITH LABS
- 2005BETHANECHOL CHLORIDEGeneric (ANDA)
ANDA 040635 · UPSHER SMITH LABS
- 2005BETHANECHOL CHLORIDEGeneric (ANDA)
ANDA 040636 · UPSHER SMITH LABS
- 2004BETHANECHOL CHLORIDEGeneric (ANDA)
ANDA 040552 · ACTAVIS ELIZABETH
- 2004BETHANECHOL CHLORIDEGeneric (ANDA)
ANDA 040553 · ACTAVIS ELIZABETH
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.
