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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022408
Company: PARAPRO LLC

Summary Review

Products on NDA 022408

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NATROBA	SPINOSAD	0.9%	SUSPENSION;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022408

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/18/2011	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/2011/022408lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022408s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022408sOrig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022408Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-10	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022408Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022408Orig1s010ltr.pdf
04/28/2021	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
12/30/2014	SUPPL-5	Efficacy-Pediatric	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022408s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022408Orig1s005ltr.pdf

Labels for NDA 022408

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-10	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022408Orig1s010lbl.pdf
12/30/2014	SUPPL-5	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022408s005lbl.pdf
01/18/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022408lbl.pdf

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