Orange Book product · Generic (ANDA)
AMANTADINE HYDROCHLORIDE
AMANTADINE HYDROCHLORIDE
At a glance
Mar 10, 2020
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 10, 2020
6 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
AMANTADINE HYDROCHLORIDE
Strength
100MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 210215
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
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NDA 016023 · ENDO PHARMS
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NDA 018101 · ENDO PHARMS
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ANDA 212407 · ADAPTIS
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ANDA 211354 · ONESOURCE SPECIALTY
- 2021AMANTADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214178 · POM PHARMA
- 2020AMANTADINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214284 · ALEMBIC
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.
