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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018827

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NDA 018827 describes LOTRISONE, which is a drug marketed by Merck Sharp Dohme and is included in two NDAs. It is available from three suppliers. Additional details are available on the LOTRISONE profile page.

The generic ingredient in LOTRISONE is betamethasone dipropionate; clotrimazole. There are sixty-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.

Summary for NDA: 018827

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 018827

Ingredient-typeAzoles
Mechanism of ActionCorticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 018827

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOTRISONE
betamethasone dipropionate; clotrimazole
CREAM;TOPICAL 018827 NDA Merck Sharp & Dohme Corp. 0085-0924 0085-0924-01 1 TUBE in 1 BOX (0085-0924-01) > 15 g in 1 TUBE
LOTRISONE
betamethasone dipropionate; clotrimazole
CREAM;TOPICAL 018827 NDA Merck Sharp & Dohme Corp. 0085-0924 0085-0924-02 1 TUBE in 1 BOX (0085-0924-02) > 45 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrengthEQ 0.05% BASE;1%
Approval Date:Jul 10, 1984TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 018827

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
LOTRISONE
betamethasone dipropionate; clotrimazole
CREAM;TOPICAL018827-001Jul 10, 19844,298,604► Subscribe
Merck Sharp Dohme
LOTRISONE
betamethasone dipropionate; clotrimazole
CREAM;TOPICAL018827-001Jul 10, 19843,660,577► Subscribe
Merck Sharp Dohme
LOTRISONE
betamethasone dipropionate; clotrimazole
CREAM;TOPICAL018827-001Jul 10, 19843,839,573► Subscribe
Merck Sharp Dohme
LOTRISONE
betamethasone dipropionate; clotrimazole
CREAM;TOPICAL018827-001Jul 10, 19843,705,172► Subscribe
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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Covington
Baxter
Accenture
Federal Trade Commission
McKinsey
Argus Health
US Army
Express Scripts
Cerilliant

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