Details for New Drug Application (NDA): 204096

NDA 204096 describes ASTAGRAF XL, which is a drug marketed by Astellas and is included in one NDA. It is available from one supplier. Additional details are available on the ASTAGRAF XL profile page.

The generic ingredient in ASTAGRAF XL 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 204096

Tradename:	ASTAGRAF XL
Applicant:	Astellas
Ingredient:	tacrolimus
Patents:	0

Pharmacology for NDA: 204096

Mechanism of Action

Calcineurin Inhibitors

Medical Subject Heading (MeSH) Categories for 204096

Calcineurin Inhibitors

Immunosuppressive Agents

Suppliers and Packaging for NDA: 204096

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096	NDA	Astellas Pharma US, Inc.	0469-0647	0469-0647-11	5 BLISTER PACK in 1 CARTON (0469-0647-11) / 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK
ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096	NDA	Astellas Pharma US, Inc.	0469-0647	0469-0647-73	1 BOTTLE in 1 CARTON (0469-0647-73) / 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	Jul 19, 2013	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	May 24, 2025
Regulatory Exclusivity Use:	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	EQ 1MG BASE
Approval Date:	Jul 19, 2013	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	May 24, 2025
Regulatory Exclusivity Use:	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jul 19, 2013	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	May 24, 2025
Regulatory Exclusivity Use:	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)

Expired US Patents for NDA 204096

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013	6,576,259
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013	6,440,458
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013	6,440,458
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-001	Jul 19, 2013	6,440,458

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