← FDA DRUG APPROVALS

FDA ANDA · ANDA084015

BLEPH-10

Sponsor: ALLERGAN

APPLICATION
ANDA084015
TYPE
ANDA
ORIGINAL APPROVAL
1975-01-07
LATEST ACTION
2001-08-15
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

BLEPH-10Discontinued
SULFACETAMIDE SODIUM 10% · OINTMENT · OPHTHALMIC

Approval history

2001-08-15Manufacturing (CMC) · Supplement 19AP
2001-06-08Manufacturing (CMC) · Supplement 20AP
1999-11-15Manufacturing (CMC) · Supplement 18AP
1998-06-24Manufacturing (CMC) · Supplement 17AP
1998-03-27Manufacturing (CMC) · Supplement 16AP
1998-03-27Manufacturing (CMC) · Supplement 14AP
1998-03-27Manufacturing (CMC) · Supplement 15AP
1998-03-27Manufacturing (CMC) · Supplement 13AP
1996-12-12Labeling · Supplement 12AP
1996-12-04Manufacturing (CMC) · Supplement 11AP
1996-02-22Manufacturing (CMC) · Supplement 10AP
1994-02-08Labeling · Supplement 9AP
1993-06-29Manufacturing (CMC) · Supplement 8AP
1992-07-14Manufacturing (CMC) · Supplement 6AP
1991-04-16Manufacturing (CMC) · Supplement 4AP
1991-04-16Manufacturing (CMC) · Supplement 5AP
1988-07-22Labeling · Supplement 3AP
1988-02-12Manufacturing (CMC) · Supplement 2AP
1975-01-07OriginalAP
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 →