Product Details for ANDA 064117
MITOMYCIN (MITOMYCIN)
20MG/VIAL
Marketing Status: Prescription
40MG/VIAL
Marketing Status: Prescription
5MG/VIAL
Marketing Status: Discontinued
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: A064117
Product Number: 002
Approval Date: Apr 19, 1995
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
MITOMYCIN (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: A064117
Product Number: 002
Approval Date: Apr 19, 1995
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A064117
Product Number: 003
Approval Date: Jun 2, 1999
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
MITOMYCIN (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: A064117
Product Number: 003
Approval Date: Jun 2, 1999
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
5MG/VIAL
Marketing Status: Discontinued
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:
Application Number: A064117
Product Number: 001
Approval Date: Apr 19, 1995
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: MITOMYCIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A064117
Product Number: 001
Approval Date: Apr 19, 1995
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information