← FDA DRUG APPROVALS

FDA ANDA · ANDA213901

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA213901
TYPE
ANDA
ORIGINAL APPROVAL
2022-04-28
LATEST ACTION
2023-08-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEDiscontinued
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · CAPSULE · ORAL

Approval history

2023-08-21Labeling · Supplement 1 · standardAP
2022-04-28UNKNOWN · 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 →