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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019822
Company: GRIFFEN

Products on NDA 019822

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BIOSCRUB	CHLORHEXIDINE GLUCONATE	4%	SPONGE;TOPICAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019822

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/1989	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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
05/11/2018	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019822Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019822Orig1s008ltr.pdf
01/07/2013	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019822Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019822Orig1s007ltr.pdf
01/09/2003	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19822slr006_Pre-Scrub_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19822slr006ltr.pdf
02/13/1996	SUPPL-3	Labeling		Label is not available on this site.
04/11/1991	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 019822

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/11/2018	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019822Orig1s008lbl.pdf
01/07/2013	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019822Orig1s007lbl.pdf
01/09/2003	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19822slr006_Pre-Scrub_lbl.pdf

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

BIOSCRUB

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

SPONGE;TOPICAL; 4%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
BIOSCRUB	CHLORHEXIDINE GLUCONATE	4%	SPONGE;TOPICAL	Over-the-counter	No	019822	GRIFFEN
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	4%	SPONGE;TOPICAL	Over-the-counter	No	072525	BECTON DICKINSON

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