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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074522
Company: PHARM ASSOC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/15/1995 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
10/18/2021 SUPPL-17 Labeling-Container/Carton Labels

Label is not available on this site.

08/30/2001 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

11/19/1999 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/24/1998 SUPPL-8 Labeling

Label is not available on this site.

06/15/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/02/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/02/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/02/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/02/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/31/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/29/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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 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 075006 WOCKHARDT BIO AG
CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE 0.12% SOLUTION;DENTAL Prescription No AT 077789 XTTRIUM
PAROEX CHLORHEXIDINE GLUCONATE 0.12% SOLUTION;DENTAL Prescription No AT 076434 SUNSTAR AMERICAS
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
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