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Federal Trade Commission
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Johnson and Johnson

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019931

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NDA 019931 describes KLARON, which is a drug marketed by Valeant Pharms North and is included in one NDA. It is available from three suppliers. Additional details are available on the KLARON profile page.

The generic ingredient in KLARON is sulfacetamide sodium. There are three drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the sulfacetamide sodium profile page.
Summary for 019931
Applicant:Valeant Pharms North
Ingredient:sulfacetamide sodium
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 019931
Medical Subject Heading (MeSH) Categories for 019931
Suppliers and Packaging for NDA: 019931
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KLARON sulfacetamide sodium LOTION;TOPICAL 019931 NDA Valeant Pharmaceuticals North America LLC 0187-5198 N 0187-5198-04
KLARON sulfacetamide sodium LOTION;TOPICAL 019931 NDA Physicians Total Care, Inc. 54868-5401 E 54868-5401-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength10%
Approval Date:Dec 23, 1996TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
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Queensland Health

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