← FDA DRUG APPROVALS

FDA ANDA · ANDA206892

OLANZAPINE

Sponsor: HISUN PHARM HANGZHOU

APPLICATION
ANDA206892
TYPE
ANDA
ORIGINAL APPROVAL
2020-12-31
LATEST ACTION
2020-12-31
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription

Products

OLANZAPINEPrescription
OLANZAPINE 15MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEPrescription
OLANZAPINE 5MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEPrescription
OLANZAPINE 20MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEPrescription
OLANZAPINE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2020-12-31UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →