Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020111
Company: BAJAJ
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
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.

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

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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