← FDA Drug Approvals (Drugs@FDA)

ASENAPINE MALEATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2020-12-10

Drug application

FDA Application #

ANDA206098

Application type

Abbreviated New Drug Application (Generic)

Brand name

ASENAPINE MALEATE

Generic name

ASENAPINE

Active ingredients

ASENAPINE MALEATE

Dosage form

TABLET

Route

SUBLINGUAL

Marketing status

Prescription

Sponsor

ALEMBIC

Manufacturer

Alembic Pharmaceuticals Limited

First approval

2020-12-10

Source

Authoritative

Drugs@FDA application overview

Machine

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