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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 019796

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NDA 019796 describes ELOCON, which is a drug marketed by Merck Sharp Dohme and is included in three NDAs. It is available from one supplier. Additional details are available on the ELOCON profile page.

The generic ingredient in ELOCON is mometasone furoate. There are thirty drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.
Summary for 019796
Applicant:Merck Sharp Dohme
Ingredient:mometasone furoate
Formulation / Manufacturing:see details
Pharmacology for NDA: 019796
Medical Subject Heading (MeSH) Categories for 019796
Suppliers and Packaging for NDA: 019796
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELOCON mometasone furoate LOTION;TOPICAL 019796 NDA Merck Sharp & Dohme Corp. 0085-0854 0085-0854-01 1 BOTTLE in 1 BOX (0085-0854-01) > 30 mL in 1 BOTTLE
ELOCON mometasone furoate LOTION;TOPICAL 019796 NDA Merck Sharp & Dohme Corp. 0085-0854 0085-0854-02 1 BOTTLE in 1 BOX (0085-0854-02) > 60 mL in 1 BOTTLE
Paragraph IV (Patent) Challenges for 019796
Tradename Dosage Ingredient NDA Submissiondate
ELOCON LOTION;TOPICAL mometasone furoate 019796 2004-06-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.1%
Approval Date:Mar 30, 1989TE:ABRLD:Yes

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