Details for New Drug Application (NDA): 050708
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NDA 050708 describes PROGRAF, which is a drug marketed by Astellas and is included in three NDAs. It is available from one supplier. Additional details are available on the PROGRAF profile page.
The generic ingredient in PROGRAF 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 PROGRAF 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 050708
| Tradename: | PROGRAF |
| Applicant: | Astellas |
| Ingredient: | tacrolimus |
| Patents: | 0 |
Pharmacology for NDA: 050708
| Mechanism of Action | Calcineurin Inhibitors |
Medical Subject Heading (MeSH) Categories for 050708
Suppliers and Packaging for NDA: 050708
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROGRAF | tacrolimus | CAPSULE;ORAL | 050708 | NDA | Astellas Pharma US, Inc. | 0469-0607 | 0469-0607-73 | 1 BOTTLE in 1 CARTON (0469-0607-73) / 100 CAPSULE, GELATIN COATED in 1 BOTTLE |
| PROGRAF | tacrolimus | CAPSULE;ORAL | 050708 | NDA | Astellas Pharma US, Inc. | 0469-0617 | 0469-0617-73 | 1 BOTTLE in 1 CARTON (0469-0617-73) / 100 CAPSULE, GELATIN COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Apr 8, 1994 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jul 16, 2028 | ||||||||
| Regulatory Exclusivity Use: | FOR PROPHYLAXIS OF ORGAN REJECTION IN ADULT AND PEDIATRIC PATIENTS RECEIVING ALLOGENEIC LUNG TRANSPLANT | ||||||||
| Regulatory Exclusivity Expiration: | May 24, 2025 | ||||||||
| Regulatory Exclusivity Use: | PROPHYLAXIS OF ORGAN REJECTION IN PEDIATRIC PATIENTS RECEIVING ALLOGENEIC KIDNEY OR HEART TRANSPLANTS, IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Apr 8, 1994 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jul 16, 2028 | ||||||||
| Regulatory Exclusivity Use: | FOR PROPHYLAXIS OF ORGAN REJECTION IN ADULT AND PEDIATRIC PATIENTS RECEIVING ALLOGENEIC LUNG TRANSPLANT | ||||||||
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