Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077789
Company: XTTRIUM

Products on ANDA 077789

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION;DENTAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077789

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/18/2009	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/08/2023	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/28/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077789

CHLORHEXIDINE GLUCONATE

SOLUTION;DENTAL; 0.12%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION;DENTAL	Prescription	No	AT	075561	BAJAJ
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION;DENTAL	Prescription	No	AT	075006	CHARTWELL RX
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION;DENTAL	Prescription	No	AT	074291	LYNE
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION;DENTAL	Prescription	No	AT	074522	PHARM ASSOC
CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION;DENTAL	Prescription	No	AT	077789	XTTRIUM
PERIDEX	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION;DENTAL	Prescription	Yes	AT	019028	3M
PERIOGARD	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION;DENTAL	Prescription	No	AT	203212	COLGATE-PALMOLIVE CO