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Generated: November 21, 2018

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Details for New Drug Application (NDA): 050734

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NDA 050734 describes IDAMYCIN PFS, which is a drug marketed by Pharmacia And Upjohn and is included in one NDA. It is available from one supplier. Additional details are available on the IDAMYCIN PFS profile page.

The generic ingredient in IDAMYCIN PFS is idarubicin hydrochloride. There are six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the idarubicin hydrochloride profile page.
Summary for 050734
Tradename:IDAMYCIN PFS
Applicant:Pharmacia And Upjohn
Ingredient:idarubicin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050734
Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors
Medical Subject Heading (MeSH) Categories for 050734
Suppliers and Packaging for NDA: 050734
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IDAMYCIN PFS idarubicin hydrochloride INJECTABLE;INJECTION 050734 NDA Pharmacia and Upjohn Company LLC 0013-2576 0013-2576-91 1 VIAL in 1 CARTON (0013-2576-91) > 5 mL in 1 VIAL
IDAMYCIN PFS idarubicin hydrochloride INJECTABLE;INJECTION 050734 NDA Pharmacia and Upjohn Company LLC 0013-2586 0013-2586-91 1 VIAL in 1 CARTON (0013-2586-91) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Feb 17, 1997TE:APRLD:Yes

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