Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208288
Company: 3M HEALTH CARE

Products on NDA 208288

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOLUPREP S	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	2%;70%	SOLUTION;TOPICAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208288

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/08/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208288s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208288Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208288Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/20/2023	SUPPL-4	Efficacy-Manufacturing Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208288Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208288Orig1s004ltr.pdf

Labels for NDA 208288

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/20/2023	SUPPL-4	Efficacy-Manufacturing Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208288Orig1s004lbl.pdf
08/08/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208288s000lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

SOLUPREP S

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

SOLUTION;TOPICAL; 2%;70%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
SOLUPREP S	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL	2%;70%	SOLUTION;TOPICAL	Over-the-counter	Yes	208288	3M HEALTH CARE