← FDA DRUG APPROVALS

FDA ANDA · ANDA204296

DROSPIRENONE AND ETHINYL ESTRADIOL

Sponsor: GLENMARK PHARMS LTD

APPLICATION
ANDA204296
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-17
LATEST ACTION
2024-02-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DROSPIRENONE AND ETHINYL ESTRADIOLPrescription
DROSPIRENONE 3MG, ETHINYL ESTRADIOL 0.02MG · TABLET · ORAL

Approval history

2024-02-22Labeling · Supplement 7 · standardAP
2024-02-22Labeling · Supplement 5 · standardAP
2020-07-17Labeling · Supplement 1 · standardAP
2015-08-17UNKNOWN · OriginalAP
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 →