← FDA DRUG APPROVALS

FDA NDA · NDA022368

ARIDOL BRONCHIAL CHALLENGE TEST KIT

mannitol

Sponsor: PHARMAXIS EUROPE

APPLICATION
NDA022368
TYPE
NDA
ORIGINAL APPROVAL
2010-10-05
LATEST ACTION
2021-08-13
ROUTE
INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ARIDOL KIT · ReferencePrescription
MANNITOL N/A,5MG,10MG,20MG,40MG · POWDER · INHALATION
ARIDOLPrescription
MANNITOL 40MG · POWDER · INHALATION
ARIDOLPrescription
MANNITOL 10MG · POWDER · INHALATION
ARIDOLPrescription
MANNITOL 20MG · POWDER · INHALATION

Approval history

2021-08-13Labeling · Supplement 3 · standard — Letter ↗AP
2010-10-05Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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