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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 065185

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BLEOMYCIN SULFATE (BLEOMYCIN SULFATE)
EQ 15 UNITS BASE/VIAL
Marketing Status: Prescription
Active Ingredient: BLEOMYCIN SULFATE
Proprietary Name: BLEOMYCIN SULFATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 15 UNITS BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A065185
Product Number: 001
Approval Date: Jan 28, 2008
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
BLEOMYCIN SULFATE (BLEOMYCIN SULFATE)
EQ 30 UNITS BASE/VIAL
Marketing Status: Prescription
Active Ingredient: BLEOMYCIN SULFATE
Proprietary Name: BLEOMYCIN SULFATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 30 UNITS BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A065185
Product Number: 002
Approval Date: Jan 28, 2008
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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