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Sertaconazole nitrate - Generic Drug Details

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Sertaconazole nitrate is the generic ingredient in one branded drug marketed by Valeant Luxembourg and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for sertaconazole nitrate. Two suppliers are listed for this compound.

Summary for Generic Name: sertaconazole nitrate

Tradenames:1
Patents:0
Applicants:1
NDAs:1
Drug Master File Entries: see list1
Suppliers / Packaging: see list2
Therapeutic Class:Antifungals

Pharmacology for Ingredient: sertaconazole nitrate

Ingredient-typeAzoles
Drug ClassAzole Antifungal

Clinical Trials for: sertaconazole nitrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Luxembourg
ERTACZO
sertaconazole nitrate
CREAM;TOPICAL021385-001Dec 10, 2003RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: sertaconazole nitrate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Luxembourg
ERTACZO
sertaconazole nitrate
CREAM;TOPICAL021385-001Dec 10, 20035,135,943<disabled>
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