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Last Updated: May 20, 2022

Details for New Drug Application (NDA): 050709


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NDA 050709 describes PROGRAF, which is a drug marketed by Astellas and is included in three NDAs. 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. Additional details are available on the tacrolimus profile page.
Summary for 050709
Tradename:PROGRAF
Applicant:Astellas
Ingredient:tacrolimus
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050709
Mechanism of Action Calcineurin Inhibitors
Medical Subject Heading (MeSH) Categories for 050709

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Apr 8, 1994TE:APRLD: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

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Serving leading biopharmaceutical companies globally:

McKinsey
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Baxter
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McKesson
Boehringer Ingelheim

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