Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019931
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KLARON SULFACETAMIDE SODIUM 10% LOTION;TOPICAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/23/1996 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019931ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/16/2016 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/27/2015 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

12/05/2014 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/02/2010 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019931s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019931s019ltr.pdf
02/21/2003 SUPPL-8 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19931slr008_Aventis_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19931slr008ltr.pdf
10/09/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/09/2002 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/12/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/12/2002 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/26/2002 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/15/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/02/2010 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019931s019lbl.pdf
02/21/2003 SUPPL-8 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19931slr008_Aventis_lbl.pdf

KLARON

LOTION;TOPICAL; 10%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KLARON SULFACETAMIDE SODIUM 10% LOTION;TOPICAL Prescription Yes AB 019931 BAUSCH
SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM 10% LOTION;TOPICAL Prescription No AB 077015 FOUGERA PHARMS
SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM 10% LOTION;TOPICAL Prescription No AB 078649 PADAGIS US
SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM 10% LOTION;TOPICAL Prescription No AB 078668 TARO

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