← FDA DRUG APPROVALS

FDA ANDA · ANDA078834

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA078834
TYPE
ANDA
ORIGINAL APPROVAL
2011-05-31
LATEST ACTION
2011-05-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.03MG,0.01MG, LEVONORGESTREL 0.15MG,N/A · TABLET · ORAL

Approval history

2011-05-31Original — Letter ↗AP
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 →