Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021074
Company: 3M
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AVAGARD ALCOHOL; CHLORHEXIDINE GLUCONATE 61%;1% SOLUTION;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
06/07/2001 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-074_Avagard_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21074ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-074_Avagard.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/06/2017 SUPPL-12 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021074Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021074Orig1s012ltr.pdf
11/04/2016 SUPPL-11 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021074Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021074Orig1s011ltr.pdf
11/12/2015 SUPPL-10 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021074Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021074Orig1s010ltr.pdf
02/15/2013 SUPPL-9 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/21074Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021074Orig1s009ltr.pdf
06/07/2012 SUPPL-8 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021074s008ltr.pdf
05/17/2012 SUPPL-7 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021074s007ltr.pdf
07/23/2002 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/06/2017 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021074Orig1s012lbl.pdf
11/04/2016 SUPPL-11 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021074Orig1s011lbl.pdf
11/12/2015 SUPPL-10 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021074Orig1s010lbl.pdf
02/15/2013 SUPPL-9 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/21074Orig1s009lbl.pdf
06/07/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-074_Avagard_Prntlbl.pdf

AVAGARD

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

SOLUTION;TOPICAL; 61%;1%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
AVAGARD ALCOHOL; CHLORHEXIDINE GLUCONATE 61%;1% SOLUTION;TOPICAL Over-the-counter Yes 021074 3M

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English