Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021746
Company: LEES PHARM HK

• Summary Review

Products on NDA 021746

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SURFAXIN	LUCINACTANT	8.5ML	SUSPENSION;INTRATRACHEAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021746

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/06/2012	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021746s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021746s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021746Orig1s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021746Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2014	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/03/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/10/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/19/2012	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021746

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/06/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021746s000lbl.pdf