Details for New Drug Application (NDA): 210115
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NDA 210115 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-four 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-four suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
Summary for 210115
| Tradename: | PROGRAF |
| Applicant: | Astellas |
| Ingredient: | tacrolimus |
| Patents: | 0 |
Pharmacology for NDA: 210115
| Mechanism of Action | Calcineurin Inhibitors |
Medical Subject Heading (MeSH) Categories for 210115
Suppliers and Packaging for NDA: 210115
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROGRAF | tacrolimus | FOR SUSPENSION;ORAL | 210115 | NDA | Astellas Pharma US, Inc. | 0469-1230 | 0469-1230-50 | 50 PACKET in 1 CARTON (0469-1230-50) / 1 GRANULE, FOR SUSPENSION in 1 PACKET |
| PROGRAF | tacrolimus | FOR SUSPENSION;ORAL | 210115 | NDA | Astellas Pharma US, Inc. | 0469-1330 | 0469-1330-50 | 50 PACKET in 1 CARTON (0469-1330-50) / 1 GRANULE, FOR SUSPENSION in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 0.2MG BASE/PACKET | ||||
| Approval Date: | May 24, 2018 | TE: | 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 TRANSPLANT, LIVER TRANSPLANTS, AND HEART TRANSPLANT, IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 1MG BASE/PACKET | ||||
| Approval Date: | May 24, 2018 | TE: | 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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