FDA NDA · NDA050814

CAYSTON

aztreonam

Sponsor: GILEAD

APPLICATION

NDA050814

TYPE

NDA

ORIGINAL APPROVAL

2010-02-22

LATEST ACTION

2019-11-20

ROUTE

INHALATION

DOSAGE FORM

FOR SOLUTION

MARKETING STATUS

Prescription

Products

CAYSTON · ReferencePrescription

AZTREONAM 75MG/VIAL · FOR SOLUTION · INHALATION

2019-11-20Labeling · Supplement 23 · standard — Letter ↗AP

2019-02-11Labeling · Supplement 21 · standard — Label ↗AP

2016-12-22Manufacturing (CMC) · Supplement 17 · standardAP

2015-12-28Manufacturing (CMC) · Supplement 16 · standard — Letter ↗AP

2015-02-09Manufacturing (CMC) · Supplement 10 · standardAP

2015-01-12Manufacturing (CMC) · Supplement 15 · standardAP

2014-11-10Manufacturing (CMC) · Supplement 14 · standardAP

2014-07-09Manufacturing (CMC) · Supplement 12 · standardAP

2014-05-19Manufacturing (CMC) · Supplement 13 · standardAP

2012-09-24Labeling · Supplement 7 · standard — Letter ↗AP

2010-08-20Labeling · Supplement 1 · unknown — Letter ↗AP

2010-02-22Type 3 - New Dosage Form · Original · standard — Label ↗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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