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-four 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

Pharmacology for NDA: 050777

Mechanism of Action	Calcineurin Inhibitors

Medical Subject Heading (MeSH) Categories for 050777

Calcineurin Inhibitors
Immunosuppressive Agents

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:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.03%
Approval Date:	Dec 8, 2000	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.1%
Approval Date:	Dec 8, 2000	TE:	AB	RLD:	Yes

Expired US Patents for NDA 050777

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

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