← FDA DRUG APPROVALS

FDA ANDA · ANDA206490

NORETHINDRONE ACETATE

Sponsor: INGENUS PHARMS LLC

APPLICATION
ANDA206490
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-05
LATEST ACTION
2018-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NORETHINDRONE ACETATEPrescription
NORETHINDRONE ACETATE 5MG · TABLET · ORAL

Approval history

2018-11-05UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →