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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019931
Company: BAUSCH

Products on NDA 019931

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KLARON	SULFACETAMIDE SODIUM	10%	LOTION;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019931

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.

Labels for NDA 019931

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

Therapeutic Equivalents for NDA 019931

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

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