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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203386

MITOMYCIN (MITOMYCIN)
40MG/VIAL
Marketing Status: Prescription
Active Ingredient: MITOMYCIN
Proprietary Name: MITOMYCIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 40MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A203386
Product Number: 001
Approval Date: Oct 13, 2017
Applicant Holder Full Name: RK PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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