Orange Book product · Brand (NDA)
NEOSTIGMINE METHYLSULFATE
NEOSTIGMINE METHYLSULFATE
At a glance
Sep 18, 2018
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 18, 2018
7 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
NEOSTIGMINE METHYLSULFATE
Strength
3MG/3ML (1MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 203629
Product number
003
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.
- 2013BLOXIVERZBrand (NDA)
NDA 204078 · EXELA PHARMA
- 2023NEOSTIGMINE METHYLSULFATEGeneric (ANDA)
ANDA 213244 · EUGIA PHARMA
- 2023NEOSTIGMINE METHYLSULFATEGeneric (ANDA)
ANDA 216542 · SAGENT PHARMS INC
- 2022NEOSTIGMINE METHYLSULFATEGeneric (ANDA)
ANDA 208230 · AVET LIFESCIENCES
- 2022NEOSTIGMINE METHYLSULFATEGeneric (ANDA)
ANDA 212627 · NIVAGEN PHARMS INC
- 2022NEOSTIGMINE METHYLSULFATEGeneric (ANDA)
ANDA 216206 · HIKMA
- 2022NEOSTIGMINE METHYLSULFATEGeneric (ANDA)
ANDA 216291 · DR REDDYS
- 2021NEOSTIGMINE METHYLSULFATEGeneric (ANDA)
ANDA 210652 · REGCON HOLDINGS
- 2021NEOSTIGMINE METHYLSULFATEGeneric (ANDA)
ANDA 213074 · CAPLIN
- 2021NEOSTIGMINE METHYLSULFATEGeneric (ANDA)
ANDA 212804 · MEITHEAL
- 2019NEOSTIGMINE METHYLSULFATEGeneric (ANDA)
ANDA 212968 · GLAND
- 2019NEOSTIGMINE METHYLSULFATEGeneric (ANDA)
ANDA 212512 · BE 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.
