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AMANTADINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UPSHER SMITH LABS · Approved 2002-12-16

Drug application

FDA Application #
ANDA076186
Application type
Abbreviated New Drug Application (Generic)
Brand name
AMANTADINE HYDROCHLORIDE
Generic name
AMANTADINE HYDROCHLORIDE
Active ingredients
AMANTADINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
UPSHER SMITH LABS
Manufacturer
Upsher-Smith Laboratories, LLC
First approval
2002-12-16

Source

Authoritative
Drugs@FDA application overview
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