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Last Updated: March 19, 2024

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 two 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. Thirty-six 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 Padagis Israel Pharmaceuticals Ltd 45802-390 45802-390-00 1 TUBE in 1 CARTON (45802-390-00) / 30 g in 1 TUBE
PROTOPIC tacrolimus OINTMENT;TOPICAL 050777 NDA Padagis Israel Pharmaceuticals Ltd 45802-390 45802-390-01 1 TUBE in 1 CARTON (45802-390-01) / 60 g in 1 TUBE

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

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