Orange Book product · Brand (NDA)
SYMMETREL
AMANTADINE HYDROCHLORIDE
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
AMANTADINE HYDROCHLORIDE
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 016020
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.
- 2018OSMOLEX ERBrand (NDA)
NDA 209410 · SUPERNUS PHARMS
- 2017GOCOVRIBrand (NDA)
NDA 208944 · SUPERNUS 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
- 2021AMANTADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214178 · POM PHARMA
- 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.
