Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021586
Company: 3M
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/29/2006 ORIG-1 Approval Type 4 - New Combination STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021586s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021586s000TOC.cfm
Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021586Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021586Orig1s005ltr.pdf
07/10/2013 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/20/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/11/2010 SUPPL-2 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021586s002ltr.pdf
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

DURAPREP

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPONGE;TOPICAL; EQ 0.7% IODINE;74% (6ML)
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
DURAPREP IODINE POVACRYLEX; ISOPROPYL ALCOHOL EQ 0.7% IODINE;74% (6ML) SPONGE;TOPICAL Over-the-counter Yes 021586 3M

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPONGE;TOPICAL; EQ 0.7% IODINE;74% (26ML)
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
DURAPREP IODINE POVACRYLEX; ISOPROPYL ALCOHOL EQ 0.7% IODINE;74% (26ML) SPONGE;TOPICAL Over-the-counter Yes 021586 3M

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