Orange Book product · Brand (NDA)
COGENTIN
BENZTROPINE MESYLATE
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
BENZTROPINE MESYLATE
Strength
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 012015
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.
- —COGENTINBrand (NDA)
NDA 009193 · MERCK
- 2025BENZTROPINE MESYLATEGeneric (ANDA)
ANDA 212694 · QUAGEN
- 2023BENZTROPINE MESYLATEGeneric (ANDA)
ANDA 081265 · CHARTWELL RX
- 2021BENZTROPINE MESYLATEGeneric (ANDA)
ANDA 209442 · HIKMA
- 2015BENZTROPINE MESYLATEGeneric (ANDA)
ANDA 204713 · NUVO PHARM
- 2013BENZTROPINE MESYLATEGeneric (ANDA)
ANDA 091525 · NAVINTA LLC
- 2012BENZTROPINE MESYLATEGeneric (ANDA)
ANDA 090168 · LEADING
- 2010BENZTROPINE MESYLATEGeneric (ANDA)
ANDA 091152 · LUITPOLD
- 2010BENZTROPINE MESYLATEGeneric (ANDA)
ANDA 090294 · INVAGEN PHARMS
- 2009BENZTROPINE MESYLATEGeneric (ANDA)
ANDA 090287 · HIKMA FARMACEUTICA
- 2009BENZTROPINE MESYLATEGeneric (ANDA)
ANDA 090233 · FRESENIUS KABI USA
- 2008BENZTROPINE MESYLATEGeneric (ANDA)
ANDA 040706 · OXFORD PHARMS
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.
