← FDA DRUG APPROVALS

FDA ANDA · ANDA080028

BLEPH-30

Sponsor: ALLERGAN

APPLICATION
ANDA080028
TYPE
ANDA
ORIGINAL APPROVAL
1971-05-25
LATEST ACTION
2002-11-15
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

BLEPH-30Discontinued
SULFACETAMIDE SODIUM 30% · SOLUTION/DROPS · OPHTHALMIC
BLEPH-10 · ReferenceDiscontinued
SULFACETAMIDE SODIUM 10% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2002-11-15Manufacturing (CMC) · Supplement 49AP
2002-07-03Manufacturing (CMC) · Supplement 48AP
2001-08-15Manufacturing (CMC) · Supplement 47AP
2001-08-07Manufacturing (CMC) · Supplement 45AP
2001-02-13Manufacturing (CMC) · Supplement 44AP
2000-12-08Manufacturing (CMC) · Supplement 43AP
1998-09-15Manufacturing (CMC) · Supplement 42AP
1997-11-14Manufacturing (CMC) · Supplement 40AP
1997-11-14Manufacturing (CMC) · Supplement 41AP
1994-09-27Manufacturing (CMC) · Supplement 38AP
1994-06-14Labeling · Supplement 39AP
1993-06-29Manufacturing (CMC) · Supplement 37AP
1993-01-27Labeling · Supplement 36AP
1991-12-12Manufacturing (CMC) · Supplement 28AP
1991-12-12Manufacturing (CMC) · Supplement 32AP
1991-12-12Manufacturing (CMC) · Supplement 30AP
1991-12-12Manufacturing (CMC) · Supplement 29AP
1991-12-12Labeling · Supplement 35AP
1991-12-12Manufacturing (CMC) · Supplement 31AP
1991-03-27Labeling · Supplement 26AP
1989-05-02Manufacturing (CMC) · Supplement 33AP
1988-03-29Manufacturing (CMC) · Supplement 27AP
1986-10-24Manufacturing (CMC) · Supplement 22AP
1986-10-24Manufacturing (CMC) · Supplement 23AP
1983-12-05Manufacturing (CMC) · Supplement 20AP
1982-09-28Manufacturing (CMC) · Supplement 12AP
1982-09-28Manufacturing (CMC) · Supplement 13AP
1982-08-16Manufacturing (CMC) · Supplement 18AP
1982-07-22Manufacturing (CMC) · Supplement 15AP
1971-05-25OriginalAP
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 →