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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 089454

PROTAMINE SULFATE (PROTAMINE SULFATE)
10MG/ML
Marketing Status: Prescription
Active Ingredient: PROTAMINE SULFATE
Proprietary Name: PROTAMINE SULFATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A089454
Product Number: 001
Approval Date: Apr 7, 1987
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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