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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 200219

OXYTOCIN (OXYTOCIN)
10USP UNITS/ML (10USP UNITS/ML)
Marketing Status: Prescription
Active Ingredient: OXYTOCIN
Proprietary Name: OXYTOCIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10USP UNITS/ML (10USP UNITS/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A200219
Product Number: 001
Approval Date: Feb 13, 2013
Applicant Holder Full Name: HIKMA FARMACEUTICA PORTUGAL SA
Marketing Status:  Prescription
Patent and Exclusivity Information
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