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Generated: January 16, 2019

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Details for New Drug Application (NDA): 018751

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NDA 018751 describes SPECTAZOLE, which is a drug marketed by Alvogen Malta and is included in one NDA. It is available from two suppliers. Additional details are available on the SPECTAZOLE profile page.

The generic ingredient in SPECTAZOLE is econazole nitrate. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the econazole nitrate profile page.
Summary for 018751
Tradename:SPECTAZOLE
Applicant:Alvogen Malta
Ingredient:econazole nitrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018751
Medical Subject Heading (MeSH) Categories for 018751
Suppliers and Packaging for NDA: 018751
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPECTAZOLE econazole nitrate CREAM;TOPICAL 018751 NDA Alvogen Inc. 47781-543 47781-543-72 1 TUBE in 1 CARTON (47781-543-72) > 15 g in 1 TUBE
SPECTAZOLE econazole nitrate CREAM;TOPICAL 018751 NDA Alvogen Inc. 47781-543 47781-543-73 1 TUBE in 1 CARTON (47781-543-73) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Dec 23, 1982TE:ABRLD:Yes

Expired US Patents for NDA 018751

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen Malta SPECTAZOLE econazole nitrate CREAM;TOPICAL 018751-001 Dec 23, 1982 ➤ Sign Up ➤ Sign Up
Alvogen Malta SPECTAZOLE econazole nitrate CREAM;TOPICAL 018751-001 Dec 23, 1982 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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