← FDA DRUG APPROVALS

FDA ANDA · ANDA210087

FINZALA

norethindrone acetate and ethinyl estradiol and ferrous fumarate

Sponsor: TEVA PHARMS USA INC

APPLICATION
ANDA210087
TYPE
ANDA
ORIGINAL APPROVAL
2020-04-07
LATEST ACTION
2024-02-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FINZALAPrescription
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL

Approval history

2024-02-27Labeling · Supplement 9 · standardAP
2023-06-21Labeling · Supplement 5 · standardAP
2020-04-07UNKNOWN · 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 →