Orange Book product · Generic (ANDA)
AMANTADINE HYDROCHLORIDE
AMANTADINE HYDROCHLORIDE
At a glance
Aug 20, 2021
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 20, 2021
4 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
AMANTADINE HYDROCHLORIDE
Strength
50MG/5ML
Dosage form
SYRUP
Route
ORAL
TE code
AA
Application
ANDA 214178
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AMANTADINE HYDROCHLORIDE
- 2018OSMOLEX ERBrand (NDA)
NDA 209410 · SUPERNUS PHARMS
- 2017GOCOVRIBrand (NDA)
NDA 208944 · SUPERNUS PHARMS
- —SYMMETRELBrand (NDA)
NDA 016020 · ENDO PHARMS
- —SYMMETRELBrand (NDA)
NDA 016023 · ENDO PHARMS
- —SYMMETRELBrand (NDA)
NDA 018101 · ENDO PHARMS
- 2024AMANTADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218598 · ZHEJIANG JUTAI PHARM
- 2024AMANTADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214897 · ZYDUS
- 2022AMANTADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214580 · HUMANWELL PURACAP
- 2022AMANTADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212407 · ADAPTIS
- 2022AMANTADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 211354 · ONESOURCE SPECIALTY
- 2020AMANTADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214284 · ALEMBIC
- 2020AMANTADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212044 · RUBICON RESEARCH
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.
