FDA NDA · NDA050810

AZASITE

azithromycin monohydrate

Sponsor: THEA PHARMA

APPLICATION

NDA050810

TYPE

NDA

ORIGINAL APPROVAL

2007-04-27

LATEST ACTION

2024-07-25

ROUTE

OPHTHALMIC

DOSAGE FORM

SOLUTION/DROPS

MARKETING STATUS

Prescription

Products

AZASITE · ReferencePrescription

AZITHROMYCIN 1% · SOLUTION/DROPS · OPHTHALMIC

2024-07-25Labeling · Supplement 17 · standard — Letter ↗AP

2021-11-17Labeling · Supplement 19 · standard — Letter ↗AP

2013-03-12Manufacturing (CMC) · Supplement 15 · standardAP

2012-10-16Manufacturing (CMC) · Supplement 12 · standard — Label ↗AP

2012-07-05Labeling · Supplement 14 · standard — Label ↗AP

2011-03-31Labeling · Supplement 7 · standard — Label ↗AP

2009-05-06Labeling · Supplement 5 · standard — Letter ↗AP

2009-05-06Labeling · Supplement 1 · standard — Letter ↗AP

2009-05-06Manufacturing (CMC) · Supplement 2 — Letter ↗AP

2007-04-27Type 3 - New Dosage Form · Original · standard — Review ↗AP

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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