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-four suppliers are listed for this compound. Additional details are available on the tacrolimus 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
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 | ⤷ Sign Up | ⤷ Sign Up |
| Astellas | ASTAGRAF XL | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096-001 | Jul 19, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Astellas | ASTAGRAF XL | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096-001 | Jul 19, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Astellas | ASTAGRAF XL | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096-002 | Jul 19, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Astellas | ASTAGRAF XL | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096-002 | Jul 19, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Astellas | ASTAGRAF XL | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096-002 | Jul 19, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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