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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 two NDAs. It is available from four suppliers. Additional details are available on the PROGRAF profile page.

The generic ingredient in PROGRAF is tacrolimus. There are eighteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.

Summary for NDA: 050709

Therapeutic Class:Dermatological Agents

Pharmacology for NDA: 050709

Mechanism of ActionCalcineurin Inhibitors

Suppliers and Packaging for NDA: 050709

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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

Summary for product number 001

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

Expired Orange Book Patents for NDA: 050709

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
INJECTABLE;INJECTION050709-001Apr 8, 19945,260,301<disabled>
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