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FDA NDA · NDA022134

LASTACAFT

alcaftadine

Sponsor: ABBVIE

APPLICATION
NDA022134
TYPE
NDA
ORIGINAL APPROVAL
2010-07-28
LATEST ACTION
2022-08-29
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Over-the-counter

Products

LASTACAFT · ReferenceOver-the-counter
ALCAFTADINE 0.25% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2022-08-29Labeling · Supplement 9 · standard — Letter ↗AP
2021-12-10Efficacy · Supplement 8 · standard — Label ↗AP
2020-06-09Labeling · Supplement 7 · standard — Letter ↗AP
2015-09-30Labeling · Supplement 4 · standard — Letter ↗AP
2014-12-04Labeling · Supplement 1 · standard — Letter ↗AP
2014-08-12Manufacturing (CMC) · Supplement 2 · standardAP
2014-07-25Manufacturing (CMC) · Supplement 3 · standardAP
2010-07-28Type 1 - New Molecular Entity · Original · standard — Pediatric Medical Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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