← FDA DRUG APPROVALS

FDA NDA · NDA019845

BETOPTIC S

betaxolol hydrochloride

Sponsor: NOVARTIS

APPLICATION
NDA019845
TYPE
NDA
ORIGINAL APPROVAL
1989-12-29
LATEST ACTION
2021-06-09
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription

Products

BETOPTIC S · ReferencePrescription
BETAXOLOL HYDROCHLORIDE EQ 0.25% BASE · SUSPENSION/DROPS · OPHTHALMIC

Approval history

2021-06-09Labeling · Supplement 30 · standard — Letter ↗AP
2017-02-01Labeling · Supplement 25 · standard — Letter ↗AP
2016-06-16Manufacturing (CMC) · Supplement 27 · standardAP
2016-03-24Manufacturing (CMC) · Supplement 26 · standard — Label ↗AP
2008-05-08Labeling · Supplement 21 · standard — Label ↗AP
2007-06-08Efficacy · Supplement 20 · priority — Pediatric Written Request ↗AP
2003-05-09Labeling · Supplement 17 · standard — Label ↗AP
2002-12-04Manufacturing (CMC) · Supplement 16 · standardAP
2001-03-16Manufacturing (CMC) · Supplement 15 · standardAP
2000-02-18Manufacturing (CMC) · Supplement 14 · standardAP
1999-08-17Manufacturing (CMC) · Supplement 13 · standardAP
1999-04-07Manufacturing (CMC) · Supplement 12 · standardAP
1999-04-05Manufacturing (CMC) · Supplement 11 · standardAP
1999-03-11Manufacturing (CMC) · Supplement 9 · standardAP
1999-02-23Manufacturing (CMC) · Supplement 7 · standardAP
1999-02-05Manufacturing (CMC) · Supplement 10 · standardAP
1998-10-14Manufacturing (CMC) · Supplement 8 · standardAP
1998-08-27Manufacturing (CMC) · Supplement 6 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 4 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 5 · standardAP
1993-01-22Manufacturing (CMC) · Supplement 3 · standardAP
1991-04-10Manufacturing (CMC) · Supplement 2 · standardAP
1990-12-20Labeling · Supplement 1AP
1989-12-29Type 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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