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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020111
Company: BAJAJ

Products on NDA 020111

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION;TOPICAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020111

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/11/1997	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/22/2019	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020111Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020111Orig1s013ltr.pdf
11/20/2017	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020111Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020111Orig1s009ltr.pdf
05/08/2013	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020111Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020111Orig1s007ltr.pdf
10/08/1999	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/16/1998	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 020111

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/22/2019	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020111Orig1s013lbl.pdf
11/20/2017	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020111Orig1s009lbl.pdf
05/08/2013	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020111Orig1s007lbl.pdf

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

CHLORHEXIDINE GLUCONATE

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

SOLUTION;TOPICAL; 0.75%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	0.75%	SOLUTION;TOPICAL	Over-the-counter	No	020111	BAJAJ

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