FDA NDA · NDA020597

LATANOPROST

Sponsor: UPJOHN

APPLICATION

NDA020597

TYPE

NDA

ORIGINAL APPROVAL

1996-06-05

LATEST ACTION

2022-12-19

ROUTE

OPHTHALMIC

DOSAGE FORM

SOLUTION/DROPS

MARKETING STATUS

Prescription

Products

XALATAN · ReferencePrescription

LATANOPROST 0.005% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2022-12-19Labeling · Supplement 54 · standard — Label ↗AP

2020-09-01Labeling · Supplement 52 · standard — Letter ↗AP

2017-04-10Labeling · Supplement 51 · standard — Label ↗AP

2014-11-25Labeling · Supplement 48 · standard — Letter ↗AP

2014-11-25Labeling · Supplement 45 · standard — Label ↗AP

2014-04-03Manufacturing (CMC) · Supplement 49 · priorityAP

2013-03-13Manufacturing (CMC) · Supplement 46 · priority — Label ↗AP

2012-03-13Labeling · Supplement 44 · standard — Letter ↗AP

2010-08-31Labeling · Supplement 36 · standard — Letter ↗AP

2010-08-31Labeling · Supplement 35 · standard — Label ↗AP

2010-07-29Manufacturing (CMC) · Supplement 39AP

2003-07-14Labeling · Supplement 28 · standard — Letter ↗AP

2003-07-14Manufacturing (CMC) · Supplement 29 · priority — Letter ↗AP

2002-12-20Efficacy · Supplement 10 · priority — Label ↗AP

2002-11-15Manufacturing (CMC) · Supplement 26 · priority — Review ↗AP

2002-08-26Manufacturing (CMC) · Supplement 25 · priority — Label ↗AP

2002-06-21Manufacturing (CMC) · Supplement 24 · priorityAP

2001-11-26Manufacturing (CMC) · Supplement 23 · priority — Label ↗AP

2001-08-08Labeling · Supplement 19 · standard — Label ↗AP

2001-05-14Manufacturing (CMC) · Supplement 22 · priorityAP

2001-04-23Manufacturing (CMC) · Supplement 20 · priorityAP

2000-12-26Labeling · Supplement 14 · standardAP

2000-12-11Manufacturing (CMC) · Supplement 17 · priorityAP

2000-11-09Manufacturing (CMC) · Supplement 16 · priorityAP

2000-08-25Labeling · Supplement 18 · standardAP

2000-06-02Manufacturing (CMC) · Supplement 13 · priority — Review ↗AP

2000-01-24Manufacturing (CMC) · Supplement 11 · priority — Review ↗AP

1999-10-08Labeling · Supplement 12 · standardAP

1999-07-16Labeling · Supplement 8 · standardAP

1999-03-22Labeling · Supplement 7 · standardAP

1998-12-09Manufacturing (CMC) · Supplement 2 · priorityAP

1998-11-01Manufacturing (CMC) · Supplement 6 · priorityAP

1998-07-31Manufacturing (CMC) · Supplement 5 · priority — Review ↗AP

1998-06-23Labeling · Supplement 1 · standardAP

1996-06-05Type 1 - New Molecular Entity · Original · priority — Review ↗AP

VIEW ON DRUGS@FDA ↗

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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LATANOPROST

Products

Approval history

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