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ASENAPINE MALEATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BRECKENRIDGE · Approved 2021-03-09

Drug application

FDA Application #
ANDA205960
Application type
Abbreviated New Drug Application (Generic)
Brand name
ASENAPINE MALEATE
Generic name
ASENAPINE MALEATE
Active ingredients
ASENAPINE MALEATE
Dosage form
TABLET
Route
SUBLINGUAL
Marketing status
Prescription
Sponsor
BRECKENRIDGE
Manufacturer
Breckenridge Pharmaceutical, Inc.
First approval
2021-03-09

Source

Authoritative
Drugs@FDA application overview
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