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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 three suppliers. Additional details are available on the ELOCON profile page.

The generic ingredient in ELOCON is mometasone furoate. There are twenty-seven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

Summary for NDA: 019796

Tradename:
ELOCON
Applicant:
Merck Sharp Dohme
Ingredient:
mometasone furoate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 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

Summary for product number 001

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

Expired Orange Book Patents for NDA: 019796

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
ELOCON
mometasone furoate
LOTION;TOPICAL019796-001Mar 30, 19894,472,393*PED► subscribe
Merck Sharp Dohme
ELOCON
mometasone furoate
LOTION;TOPICAL019796-001Mar 30, 19894,775,529*PED► subscribe
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