Orange Book product · Generic (ANDA)
BENZTROPINE MESYLATE
BENZTROPINE MESYLATE
At a glance
Nov 29, 2023
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 29, 2023
2 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
BENZTROPINE MESYLATE
Strength
0.5MG
Dosage form
TABLET
Route
ORAL
TE code
AA
Application
ANDA 081265
Product number
003
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BENZTROPINE MESYLATE
- —COGENTINBrand (NDA)
NDA 012015 · EPIC PHARMA LLC
- —COGENTINBrand (NDA)
NDA 009193 · MERCK
- 2025BENZTROPINE MESYLATEGeneric (ANDA)
ANDA 212694 · QUAGEN
- 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.
