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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202670

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MITOMYCIN (MITOMYCIN)
5MG/VIAL
Marketing Status: Prescription
Active Ingredient: MITOMYCIN
Proprietary Name: MITOMYCIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A202670
Product Number: 001
Approval Date: Oct 13, 2017
Applicant Holder Full Name: RK PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MITOMYCIN (MITOMYCIN)
20MG/VIAL
Marketing Status: Prescription
Active Ingredient: MITOMYCIN
Proprietary Name: MITOMYCIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A202670
Product Number: 002
Approval Date: Oct 13, 2017
Applicant Holder Full Name: RK PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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