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FDA ANDA · ANDA215883

FORMOTEROL FUMARATE

formoterol fumarate dihydrate

Sponsor: MANKIND PHARMA

APPLICATION
ANDA215883
TYPE
ANDA
ORIGINAL APPROVAL
2023-03-22
LATEST ACTION
2024-07-16
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

FORMOTEROL FUMARATEPrescription
FORMOTEROL FUMARATE 0.02MG/2ML · SOLUTION · INHALATION

Approval history

2024-07-16Manufacturing (CMC) · Supplement 3 · unknownAP
2023-03-22UNKNOWN · Original · standardAP
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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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