FDA NDA · NDA020439

BETIMOL

timolol

Sponsor: THEA PHARMA

APPLICATION

NDA020439

TYPE

NDA

ORIGINAL APPROVAL

1995-03-31

LATEST ACTION

2004-10-21

ROUTE

OPHTHALMIC

DOSAGE FORM

SOLUTION/DROPS

MARKETING STATUS

Discontinued, Prescription

Products

BETIMOL · ReferenceDiscontinued

TIMOLOL 0.25% · SOLUTION/DROPS · OPHTHALMIC

BETIMOL · ReferencePrescription

TIMOLOL 0.5% · SOLUTION/DROPS · OPHTHALMIC

2004-10-21Labeling · Supplement 11 · standard — Label ↗AP

2002-02-08Manufacturing (CMC) · Supplement 9 · standardAP

2001-07-19Manufacturing (CMC) · Supplement 8 · standardAP

1999-11-30Manufacturing (CMC) · Supplement 6 · standardAP

1999-04-05Labeling · Supplement 5 · standardAP

1999-03-08Manufacturing (CMC) · Supplement 4 · standardAP

1998-09-04Manufacturing (CMC) · Supplement 3 · standardAP

1997-11-03Labeling · Supplement 2 · standardAP

1997-01-31Manufacturing (CMC) · Supplement 1 · standardAP

1995-03-31Type 2 - New Active Ingredient · 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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