FDA NDA · NDA018771

LACRISERT

Sponsor: BAUSCH AND LOMB INC

APPLICATION

NDA018771

TYPE

NDA

ORIGINAL APPROVAL

1981-06-01

LATEST ACTION

2008-10-30

ROUTE

OPHTHALMIC

DOSAGE FORM

INSERT

MARKETING STATUS

Discontinued

Products

LACRISERT · ReferenceDiscontinued

HYDROXYPROPYL CELLULOSE 5MG · INSERT · OPHTHALMIC

2008-10-30Manufacturing (CMC) · Supplement 18AP

2008-02-21Labeling · Supplement 17 · standard — Letter ↗AP

2002-11-22Manufacturing (CMC) · Supplement 13 · standardAP

2002-03-20Labeling · Supplement 12 · standard — Letter ↗AP

1998-06-02Manufacturing (CMC) · Supplement 11 · standardAP

1997-10-09Manufacturing (CMC) · Supplement 10 · standardAP

1997-06-15Labeling · Supplement 9 · standardAP

1995-08-21Manufacturing (CMC) · Supplement 8 · standardAP

1994-10-21Manufacturing (CMC) · Supplement 7 · standardAP

1988-11-01Labeling · Supplement 4AP

1988-11-01Labeling · Supplement 3AP

1988-07-01Manufacturing (CMC) · Supplement 6 · standardAP

1987-11-19Manufacturing (CMC) · Supplement 5 · standardAP

1983-01-21Manufacturing (CMC) · Supplement 2 · standardAP

1983-01-21Manufacturing (CMC) · Supplement 1 · standardAP

1981-06-01Type 3 - New Dosage Form · Original · standardAP

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

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.