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. 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.

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

Suppliers and Packaging for NDA: 050709

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROGRAF	tacrolimus	INJECTABLE;INJECTION	050709	NDA	Astellas Pharma US, Inc.	0469-3016	0469-3016-01	10 AMPULE in 1 BOX (0469-3016-01) / 1 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/ML
Approval Date:	Apr 8, 1994	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 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	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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