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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Queensland Health
Moodys
Citi
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Dow
Express Scripts
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Harvard Business School
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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050777

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NDA 050777 describes PROTOPIC, which is a drug marketed by Leo Pharma As and is included in one NDA. It is available from four suppliers. Additional details are available on the PROTOPIC profile page.

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

Summary for 050777

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 050777

Mechanism of ActionCalcineurin Inhibitors

Medical Subject Heading (MeSH) Categories for 050777

Suppliers and Packaging for NDA: 050777

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROTOPIC tacrolimus OINTMENT;TOPICAL 050777 NDA Astellas Pharma US Inc. 0469-5201 0469-5201-30 1 TUBE in 1 CARTON (0469-5201-30) > 30 g in 1 TUBE
PROTOPIC tacrolimus OINTMENT;TOPICAL 050777 NDA Astellas Pharma US Inc. 0469-5201 0469-5201-60 1 TUBE in 1 CARTON (0469-5201-60) > 60 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.03%
Approval Date:Dec 8, 2000TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.1%
Approval Date:Dec 8, 2000TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 050777

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Pharma AsPROTOPICtacrolimusOINTMENT;TOPICAL050777-001Dec 8, 2000► Subscribe► Subscribe
Leo Pharma AsPROTOPICtacrolimusOINTMENT;TOPICAL050777-002Dec 8, 2000► Subscribe► Subscribe
Leo Pharma AsPROTOPICtacrolimusOINTMENT;TOPICAL050777-002Dec 8, 2000► Subscribe► Subscribe
Leo Pharma AsPROTOPICtacrolimusOINTMENT;TOPICAL050777-001Dec 8, 2000► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Fuji
Citi
Queensland Health
Teva
Julphar
Deloitte
Cipla
Fish and Richardson
AstraZeneca

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