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FDA NDA · NDA022007

FORMOTEROL FUMARATE

formoterol fumarate dihydrate

Sponsor: VIATRIS SPECIALTY

APPLICATION
NDA022007
TYPE
NDA
ORIGINAL APPROVAL
2007-05-11
LATEST ACTION
2019-05-29
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

PERFOROMIST · ReferencePrescription
FORMOTEROL FUMARATE 0.02MG/2ML · SOLUTION · INHALATION

Approval history

2019-05-29Labeling · Supplement 15 · standard — Label ↗AP
2018-10-17Labeling · Supplement 14 · standard — Letter ↗AP
2017-11-30Labeling · Supplement 12 · standard — Label ↗AP
2014-03-19Manufacturing (CMC) · Supplement 9 · standardAP
2012-09-25REMS · Supplement 8 — Letter ↗AP
2012-09-25REMS · Supplement 7 — Letter ↗AP
2012-01-11Labeling · Supplement 6 · unknown — Letter ↗AP
2011-02-01REMS · Supplement 5 — Letter ↗AP
2010-06-02Labeling · Supplement 4 · 901 required — Letter ↗AP
2007-05-11Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP
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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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