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Last Updated: October 27, 2021

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Details for New Drug Application (NDA): 204096


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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 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 204096
Mechanism of ActionCalcineurin Inhibitors
Medical Subject Heading (MeSH) Categories for 204096
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
Paragraph IV (Patent) Challenges for 204096
Tradename Dosage Ingredient NDA Submissiondate
ASTAGRAF XL CAPSULE, EXTENDED RELEASE;ORAL tacrolimus 204096 2013-09-24

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 0.5MG BASE
Approval Date:Jul 19, 2013TE: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:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 1MG BASE
Approval Date:Jul 19, 2013TE: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:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 5MG BASE
Approval Date:Jul 19, 2013TE: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 204096-001 Jul 19, 2013 ⤷  Try it Free ⤷  Try it Free
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013 ⤷  Try it Free ⤷  Try it Free
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-002 Jul 19, 2013 ⤷  Try it Free ⤷  Try it Free
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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