Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021586
Company: SOLVENTUM

Products on NDA 21586

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DURAPREP	IODINE POVACRYLEX; ISOPROPYL ALCOHOL	EQ 0.7% IODINE;74% (6ML)	SPONGE;TOPICAL	Over-the-counter	None	Yes	Yes
DURAPREP	IODINE POVACRYLEX; ISOPROPYL ALCOHOL	EQ 0.7% IODINE;74% (26ML)	SPONGE;TOPICAL	Over-the-counter	None	Yes	Yes

Labels for NDA 021586

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/08/2015	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021586Orig1s005lbl.pdf