Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022368
Company: PHARMAXIS EUROPE

• Summary Review

Products on NDA 022368

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARIDOL	MANNITOL	10MG	POWDER; INHALATION	Prescription	None	TBD	No
ARIDOL	MANNITOL	20MG	POWDER; INHALATION	Prescription	None	TBD	No
ARIDOL	MANNITOL	40MG	POWDER; INHALATION	Prescription	None	TBD	No
ARIDOL KIT	MANNITOL	N/A,5MG,10MG,20MG,40MG	POWDER;INHALATION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022368

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/05/2010	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022368S000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022368s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022368_aridol_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022368Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/13/2021	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022368s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022368Orig1s003ltr.pdf

Labels for NDA 022368

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/13/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022368s003lbl.pdf
10/05/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022368S000lbl.pdf