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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207964
Company: MEDLINE INDUSTRIES

Products on NDA 207964

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
READYPREP CHG	CHLORHEXIDINE GLUCONATE	2%	CLOTH;TOPICAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207964

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/2018	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207964Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207964Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/207964Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/24/2023	SUPPL-3	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207964Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207964Orig1s003ltr.pdf

Labels for NDA 207964

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/24/2023	SUPPL-3	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207964Orig1s003lbl.pdf
11/20/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207964Orig1s000lbl.pdf

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

READYPREP CHG

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

CLOTH;TOPICAL; 2%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	2%	CLOTH;TOPICAL	Over-the-counter	Yes	021669	SAGE PRODS
READYPREP CHG	CHLORHEXIDINE GLUCONATE	2%	CLOTH;TOPICAL	Over-the-counter	No	207964	MEDLINE INDUSTRIES

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