← FDA Drug Approvals (Drugs@FDA)

OLANZAPINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ROXANE · Approved 2006-09-29

Drug application

FDA Application #

ANDA077993

Application type

Abbreviated New Drug Application (Generic)

Brand name

OLANZAPINE

Generic name

Olanzapine

Active ingredients

OLANZAPINE

Dosage form

TABLET

Route

ORAL

Marketing status

None (Tentative Approval)

Sponsor

ROXANE

First approval

2006-09-29

Source

Authoritative

Drugs@FDA application overview

Machine

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