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Last Updated: July 2, 2020

DrugPatentWatch Database Preview

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. Twenty-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
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 0469-0647-73 1 BOTTLE in 1 CARTON (0469-0647-73) > 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE
ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096 NDA Astellas Pharma US, Inc. 0469-0677 0469-0677-73 1 BOTTLE in 1 CARTON (0469-0677-73) > 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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 1MG BASE
Approval Date:Jul 19, 2013TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 5MG BASE
Approval Date:Jul 19, 2013TE:RLD:Yes

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 204096-002 Jul 19, 2013   Start Trial   Start Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-002 Jul 19, 2013   Start Trial   Start Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-001 Jul 19, 2013   Start Trial   Start Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-002 Jul 19, 2013   Start Trial   Start Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-001 Jul 19, 2013   Start Trial   Start Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-001 Jul 19, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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