Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020111
Company: BAJAJ
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 |