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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018243

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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: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N018243
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
OXYTOCIN (OXYTOCIN)
100USP UNITS/10ML (10USP UNITS/ML)
Marketing Status: Prescription
Active Ingredient: OXYTOCIN
Proprietary Name: OXYTOCIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 100USP UNITS/10ML (10USP UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N018243
Product Number: 002
Approval Date: Jan 10, 2007
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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