APPLICATION
ANDA080027
TYPE
ANDA
ORIGINAL APPROVAL
1971-12-22
LATEST ACTION
2024-05-30
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
ALCAINEPrescription
PROPARACAINE HYDROCHLORIDE 0.5% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2024-05-30Labeling · Supplement 51 · standardAP
2022-09-09Labeling · Supplement 47 · standardAP
2005-04-04Labeling · Supplement 35AP
2003-08-06Labeling · Supplement 33AP
2002-12-23Manufacturing (CMC) · Supplement 32AP
2001-03-01Manufacturing (CMC) · Supplement 31AP
2001-03-01Manufacturing (CMC) · Supplement 30AP
2000-08-11Labeling · Supplement 29AP
2000-08-11Manufacturing (CMC) · Supplement 23AP
2000-04-28Manufacturing (CMC) · Supplement 28AP
1999-05-07Manufacturing (CMC) · Supplement 25AP
1999-04-21Manufacturing (CMC) · Supplement 27AP
1999-03-23Manufacturing (CMC) · Supplement 26AP
1999-03-04Manufacturing (CMC) · Supplement 24AP
1996-06-14Labeling · Supplement 22AP
1995-10-05Manufacturing (CMC) · Supplement 21AP
1995-08-04Manufacturing (CMC) · Supplement 20AP
1993-06-04Manufacturing (CMC) · Supplement 17AP
1993-06-04Manufacturing (CMC) · Supplement 18AP
1993-04-05Labeling · Supplement 19AP
1989-12-21Labeling · Supplement 16AP
1989-05-17Labeling · Supplement 15AP
1989-04-27Manufacturing (CMC) · Supplement 14AP
1987-06-17Manufacturing (CMC) · Supplement 13AP
1971-12-22OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.