Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 064144

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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: Yes
TE Code: AP
Application Number: A064144
Product Number: 001
Approval Date: Apr 30, 1998
Applicant Holder Full Name: ACCORD HEALTHCARE 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: Yes
TE Code: AP
Application Number: A064144
Product Number: 002
Approval Date: Apr 30, 1998
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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: Yes
TE Code: AP
Application Number: A064144
Product Number: 003
Approval Date: Aug 11, 2009
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information