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

Calcineurin Inhibitors
Immunosuppressive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/ML
Approval Date:	Apr 8, 1994	TE:	AP	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

Expired US Patents for NDA 050709

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	PROGRAF	tacrolimus	INJECTABLE;INJECTION	050709-001	Apr 8, 1994	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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