Details for New Drug Application (NDA): 206406

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NDA 206406 describes ENVARSUS XR, which is a drug marketed by Veloxis Pharms Inc and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the ENVARSUS XR profile page.

The generic ingredient in ENVARSUS XR 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 206406

Tradename:	ENVARSUS XR
Applicant:	Veloxis Pharms Inc
Ingredient:	tacrolimus
Patents:	10

Pharmacology for NDA: 206406

Mechanism of Action	Calcineurin Inhibitors

Medical Subject Heading (MeSH) Categories for 206406

Calcineurin Inhibitors
Immunosuppressive Agents

Suppliers and Packaging for NDA: 206406

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406	NDA	Veloxis Pharmaceuticals, Inc	68992-3010	68992-3010-1	1 POUCH in 1 CARTON (68992-3010-1) / 1 BOTTLE in 1 POUCH / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE
ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406	NDA	Veloxis Pharmaceuticals, Inc	68992-3010	68992-3010-3	1 POUCH in 1 CARTON (68992-3010-3) / 1 BOTTLE, PLASTIC in 1 POUCH / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 0.75MG BASE
Approval Date:	Jul 10, 2015	TE:		RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	May 30, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Get Started Free	Patent Expiration:	May 30, 2028	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT
Patent:	⤷ Get Started Free	Patent Expiration:	May 30, 2028	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS

Expired US Patents for NDA 206406

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015	⤷ Get Started Free	⤷ Get Started Free
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015	⤷ Get Started Free	⤷ Get Started Free
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-001	Jul 10, 2015	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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