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VILOXAZINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APPCO PHARMA LLC · Approved 2026-04-28

Drug application

FDA Application #
ANDA220326
Application type
Abbreviated New Drug Application (Generic)
Brand name
VILOXAZINE HYDROCHLORIDE
Generic name
Viloxazine Hydrochloride
Active ingredients
VILOXAZINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
—
Marketing status
None (Tentative Approval)
Sponsor
APPCO PHARMA LLC
First approval
2026-04-28

Source

Authoritative
Drugs@FDA application overview
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