FDA Orange Book · active-ingredient family
Propantheline bromide
Propantheline bromide is approved as 2 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PRO-BANTHINE · NDA 008732
2
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PRO-BANTHINERLD×2 | SHIRE | NDA 008732 | — | Approved Prior to Jan 1, 1982 | |
| PRO-BANTHINE | GD SEARLE LLC | NDA 008843 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROPANTHELINE BROMIDE | PAR PHARM | ANDA 088377 | — | Dec 08, 1983 | |
| PROPANTHELINE BROMIDE | ASCOT | ANDA 087663 | — | Oct 25, 1982 | |
| PROPANTHELINE BROMIDE | HEATHER | ANDA 085780 | — | Approved Prior to Jan 1, 1982 | |
| PROPANTHELINE BROMIDE×2 | HIKMA | ANDA 080927 | — | Approved Prior to Jan 1, 1982 | |
| PROPANTHELINE BROMIDE | IMPAX LABS | ANDA 084541 | — | Approved Prior to Jan 1, 1982 | |
| PROPANTHELINE BROMIDE | MYLAN | ANDA 083706 | — | Approved Prior to Jan 1, 1982 | |
| PROPANTHELINE BROMIDE | PVT FORM | ANDA 080977 | — | Approved Prior to Jan 1, 1982 | |
| PROPANTHELINE BROMIDE | SANDOZ | ANDA 080928 | — | Approved Prior to Jan 1, 1982 | |
| PROPANTHELINE BROMIDE | TABLICAPS | ANDA 084428 | — | Approved Prior to Jan 1, 1982 | |
| PROPANTHELINE BROMIDE | WATSON LABS | ANDA 083029 | — | Approved Prior to Jan 1, 1982 | |
| PROPANTHELINE BROMIDE | WATSON LABS | ANDA 083151 | — | Approved Prior to Jan 1, 1982 |
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.
Propantheline bromide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
