← FDA DRUG APPROVALS

FDA ANDA · ANDA070072

BETA-VAL

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA070072
TYPE
ANDA
ORIGINAL APPROVAL
1985-06-27
LATEST ACTION
2001-08-30
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued

Products

BETA-VALDiscontinued
BETAMETHASONE VALERATE EQ 0.1% BASE · LOTION · TOPICAL

Approval history

2001-08-30Manufacturing (CMC) · Supplement 14AP
2000-07-07Manufacturing (CMC) · Supplement 13AP
2000-01-12Manufacturing (CMC) · Supplement 12AP
1996-09-13Manufacturing (CMC) · Supplement 9AP
1996-09-13Manufacturing (CMC) · Supplement 11AP
1996-09-13Manufacturing (CMC) · Supplement 10AP
1993-06-30Manufacturing (CMC) · Supplement 8AP
1993-04-01Manufacturing (CMC) · Supplement 7AP
1989-07-18Manufacturing (CMC) · Supplement 4AP
1988-11-09Manufacturing (CMC) · Supplement 5AP
1988-06-23Labeling · Supplement 3AP
1986-01-17Manufacturing (CMC) · Supplement 1AP
1985-06-27OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →