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Generated: January 23, 2019

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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 two 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-one suppliers are listed for this compound. Additional details are available on the sulfacetamide sodium profile page.
Summary for 019931
Tradename:KLARON
Applicant:Valeant Pharms North
Ingredient:sulfacetamide sodium
Patents:0
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 0187-5198-04 1 BOTTLE, PLASTIC in 1 CARTON (0187-5198-04) > 118 mL in 1 BOTTLE, PLASTIC
KLARON sulfacetamide sodium LOTION;TOPICAL 019931 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-010 68682-010-04 1 BOTTLE, PLASTIC in 1 CARTON (68682-010-04) > 118 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

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

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