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FDA NDA · NDA019814

BETAGAN

Sponsor: ALLERGAN

APPLICATION
NDA019814
TYPE
NDA
ORIGINAL APPROVAL
1989-06-28
LATEST ACTION
2003-03-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

BETAGAN · ReferenceDiscontinued
LEVOBUNOLOL HYDROCHLORIDE 0.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC

Approval history

2003-03-19Labeling · Supplement 17 · standardAP
2002-04-12Manufacturing (CMC) · Supplement 15 · standardAP
2001-12-04Manufacturing (CMC) · Supplement 14 · standardAP
2001-08-08Manufacturing (CMC) · Supplement 12 · standard — Label ↗AP
2001-05-14Labeling · Supplement 11 · standard — Label ↗AP
2001-04-12Manufacturing (CMC) · Supplement 13 · standardAP
2000-10-02Manufacturing (CMC) · Supplement 10 · standardAP
1999-01-21Manufacturing (CMC) · Supplement 7 · standardAP
1998-05-01Manufacturing (CMC) · Supplement 9 · standardAP
1997-09-18Manufacturing (CMC) · Supplement 8 · standardAP
1995-08-03Manufacturing (CMC) · Supplement 4 · standardAP
1995-06-14Manufacturing (CMC) · Supplement 5 · standardAP
1995-06-12Manufacturing (CMC) · Supplement 6 · standardAP
1992-02-03Labeling · Supplement 3AP
1990-01-18Labeling · Supplement 2AP
1990-01-04Manufacturing (CMC) · Supplement 1 · standardAP
1989-06-28Type 3 - New Dosage Form · Original · standardAP
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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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