APPLICATION
ANDA073636
TYPE
ANDA
ORIGINAL APPROVAL
1994-06-30
LATEST ACTION
2002-10-01
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
DIPIVEFRIN HYDROCHLORIDEDiscontinued
DIPIVEFRIN HYDROCHLORIDE 0.1% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2002-10-01Manufacturing (CMC) · Supplement 11AP
2002-03-28Manufacturing (CMC) · Supplement 10AP
2000-04-28Manufacturing (CMC) · Supplement 8AP
2000-04-07Manufacturing (CMC) · Supplement 9AP
1999-07-28Manufacturing (CMC) · Supplement 5AP
1999-05-07Manufacturing (CMC) · Supplement 6AP
1999-03-23Manufacturing (CMC) · Supplement 7AP
1999-03-04Manufacturing (CMC) · Supplement 4AP
1998-02-17Manufacturing (CMC) · Supplement 3AP
1995-10-05Manufacturing (CMC) · Supplement 2AP
1995-08-04Manufacturing (CMC) · Supplement 1AP
1994-06-30OriginalAP
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.