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Generated: April 28, 2017

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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 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-three suppliers are listed for this compound. Additional details are available on the sulfacetamide sodium profile page.

Summary for NDA: 019931

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 019931


Suppliers and Packaging for NDA: 019931

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sulfacetamide sodium
LOTION;TOPICAL 019931 NDA Valeant Pharmaceuticals North America LLC 0187-5198 0187-5198-04 118 mL in 1 BOTTLE, PLASTIC (0187-5198-04)
sulfacetamide sodium
LOTION;TOPICAL 019931 NDA Physicians Total Care, Inc. 54868-5401 54868-5401-0 118 mL in 1 BOTTLE, PLASTIC (54868-5401-0)

Summary for product number 001

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

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