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AMANTADINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ONESOURCE SPECIALTY · Approved 2022-02-18

Drug application

FDA Application #
ANDA211354
Application type
Abbreviated New Drug Application (Generic)
Brand name
AMANTADINE HYDROCHLORIDE
Generic name
AMANTADINE HYDROCHLORIDE
Active ingredients
AMANTADINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
ONESOURCE SPECIALTY
Manufacturer
Strides Pharma Science Limited
First approval
2022-02-18

Source

Authoritative
Drugs@FDA application overview
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