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-five 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-five 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 | 0469-0647-73 | 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 |
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 | ||||
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 | ||||
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 | ||||
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 | ⤷ Get Started Free | ⤷ Get Started Free |
| Astellas | ASTAGRAF XL | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096-001 | Jul 19, 2013 | ⤷ Get Started Free | ⤷ Get Started Free |
| Astellas | ASTAGRAF XL | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096-002 | Jul 19, 2013 | ⤷ Get Started Free | ⤷ Get Started Free |
| Astellas | ASTAGRAF XL | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096-002 | Jul 19, 2013 | ⤷ Get Started Free | ⤷ Get Started Free |
| Astellas | ASTAGRAF XL | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096-003 | Jul 19, 2013 | ⤷ Get Started Free | ⤷ Get Started Free |
| Astellas | ASTAGRAF XL | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096-002 | Jul 19, 2013 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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