Orange Book product · Brand (NDA)
PRO-BANTHINE
PROPANTHELINE BROMIDE
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
PROPANTHELINE BROMIDE
Strength
7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 008732
Product number
003
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.
- —PRO-BANTHINEBrand (NDA)
NDA 008843 · GD SEARLE LLC
- 1983PROPANTHELINE BROMIDEGeneric (ANDA)
ANDA 088377 · PAR PHARM
- 1982PROPANTHELINE BROMIDEGeneric (ANDA)
ANDA 087663 · ASCOT
- —PROPANTHELINE BROMIDEGeneric (ANDA)
ANDA 085780 · HEATHER
- —PROPANTHELINE BROMIDEGeneric (ANDA)
ANDA 080927 · HIKMA
- —PROPANTHELINE BROMIDEGeneric (ANDA)
ANDA 084541 · IMPAX LABS
- —PROPANTHELINE BROMIDEGeneric (ANDA)
ANDA 083706 · MYLAN
- —PROPANTHELINE BROMIDEGeneric (ANDA)
ANDA 080977 · PVT FORM
- —PROPANTHELINE BROMIDEGeneric (ANDA)
ANDA 080928 · SANDOZ
- —PROPANTHELINE BROMIDEGeneric (ANDA)
ANDA 084428 · TABLICAPS
- —PROPANTHELINE BROMIDEGeneric (ANDA)
ANDA 083029 · WATSON LABS
- —PROPANTHELINE BROMIDEGeneric (ANDA)
ANDA 083151 · WATSON LABS
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.
