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Last Updated: September 26, 2022

Details for New Drug Application (NDA): 064117


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NDA 064117 describes MITOMYCIN, which is a drug marketed by Accord Hlthcare, Gland Pharma Ltd, Hikma, Hospira, and Rk Pharma, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the MITOMYCIN profile page.

The generic ingredient in MITOMYCIN is mitomycin. There are seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the mitomycin profile page.
Summary for 064117
Tradename:MITOMYCIN
Applicant:Hikma
Ingredient:mitomycin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 064117
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 064117
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MITOMYCIN mitomycin INJECTABLE;INJECTION 064117 ANDA West-Ward Pharmaceuticals Corp 0143-9279 0143-9279-01 1 VIAL in 1 BOX, UNIT-DOSE (0143-9279-01) > 40 mL in 1 VIAL
MITOMYCIN mitomycin INJECTABLE;INJECTION 064117 ANDA West-Ward Pharmaceuticals Corp 0143-9280 0143-9280-01 1 VIAL in 1 BOX, UNIT-DOSE (0143-9280-01) > 80 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength5MG/VIAL
Approval Date:Apr 19, 1995TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/VIAL
Approval Date:Apr 19, 1995TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/VIAL
Approval Date:Jun 2, 1999TE:APRLD:No

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