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Last Updated: January 20, 2020

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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 three 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-two suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
Summary for 050777
Tradename:PROTOPIC
Applicant:Leo Pharma As
Ingredient:tacrolimus
Patents:0
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 0469-5201-02 1 TUBE in 1 CARTON (0469-5201-02) > 2 g in 1 TUBE
PROTOPIC tacrolimus OINTMENT;TOPICAL 050777 NDA Astellas Pharma US Inc. 0469-5201 0469-5201-11 1 TUBE in 1 CARTON (0469-5201-11) > 100 g in 1 TUBE
Paragraph IV (Patent) Challenges for 050777
Tradename Dosage Ingredient NDA Submissiondate
PROTOPIC OINTMENT;TOPICAL tacrolimus 050777 2010-11-22
PROTOPIC OINTMENT;TOPICAL tacrolimus 050777 2010-09-09

Profile for product number 001

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

Profile for product number 002

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

Expired US Patents for NDA 050777

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-001 Dec 8, 2000   Start Trial   Start Trial
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-001 Dec 8, 2000   Start Trial   Start Trial
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-002 Dec 8, 2000   Start Trial   Start Trial
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-002 Dec 8, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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