← FDA DRUG APPROVALS

FDA NDA · NDA208612

BALCOLTRA

levonorgestrel and ethinyl estradiol

Sponsor: AVION PHARMS

APPLICATION
NDA208612
TYPE
NDA
ORIGINAL APPROVAL
2018-01-09
LATEST ACTION
2022-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BALCOLTRA · ReferencePrescription
ETHINYL ESTRADIOL 0.02MG, LEVONORGESTREL 0.1MG · TABLET · ORAL

Approval history

2022-04-29Labeling · Supplement 5 · standard — Letter ↗AP
2018-01-09Type 3 - New Dosage Form · Original · standard — Label ↗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 →