APPLICATION
NDA019907
TYPE
NDA
ORIGINAL APPROVAL
1989-12-29
LATEST ACTION
2006-11-21
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
OPTIPRANOLOL · ReferenceDiscontinued
METIPRANOLOL HYDROCHLORIDE 0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC
Approval history
2002-07-26Manufacturing (CMC) · Supplement 18 · standardAP
2001-08-30Manufacturing (CMC) · Supplement 17 · standardAP
2001-03-08Manufacturing (CMC) · Supplement 16 · standardAP
2000-11-06Manufacturing (CMC) · Supplement 15 · standardAP
2000-07-18Manufacturing (CMC) · Supplement 14 · standardAP
2000-05-17Manufacturing (CMC) · Supplement 13 · standardAP
1999-12-13Manufacturing (CMC) · Supplement 11 · standardAP
1999-12-13Labeling · Supplement 12 · standardAP
1999-05-19Manufacturing (CMC) · Supplement 10 · standardAP
1998-10-21Manufacturing (CMC) · Supplement 8 · standardAP
1998-05-20Manufacturing (CMC) · Supplement 9 · standardAP
1997-10-03Manufacturing (CMC) · Supplement 6 · standardAP
1997-10-03Manufacturing (CMC) · Supplement 5 · standardAP
1996-12-19Manufacturing (CMC) · Supplement 4 · standardAP
1996-03-21Labeling · Supplement 7 · standardAP
1995-05-11Manufacturing (CMC) · Supplement 2 · standardAP
1995-05-08Manufacturing (CMC) · Supplement 3 · standardAP
1994-08-15Manufacturing (CMC) · Supplement 1 · standardAP
1989-12-29Type 1 - New Molecular Entity · 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.
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