Orange Book product · Brand (NDA)
MESTINON
PYRIDOSTIGMINE BROMIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
PYRIDOSTIGMINE BROMIDE
Strength
5MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 009830
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2024PYRIDOSTIGMINE BROMIDEBrand (NDA)
NDA 217604 · AMNEAL
- 2003PYRIDOSTIGMINE BROMIDEBrand (NDA)
NDA 020414 · US ARMY
- —REGONOLBrand (NDA)
NDA 017398 · SANDOZ
- —MESTINONBrand (NDA)
NDA 015193 · BAUSCH
- —MESTINONBrand (NDA)
NDA 011665 · BAUSCH
- —MESTINONBrand (NDA)
NDA 009829 · BAUSCH
- 2023PYRIDOSTIGMINE BROMIDEGeneric (ANDA)
ANDA 216512 · MSN
- 2022PYRIDOSTIGMINE BROMIDEGeneric (ANDA)
ANDA 040502 · IMPAX LABS
- 2022PYRIDOSTIGMINE BROMIDEGeneric (ANDA)
ANDA 212405 · MILLA PHARMS
- 2020PYRIDOSTIGMINE BROMIDEGeneric (ANDA)
ANDA 212702 · AMNEAL
- 2020PYRIDOSTIGMINE BROMIDEGeneric (ANDA)
ANDA 208797 · RISING
- 2019PYRIDOSTIGMINE BROMIDEGeneric (ANDA)
ANDA 211181 · MLV
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.
