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Federal Trade Commission
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Harvard Business School

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018248

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NDA 018248 describes OXYTOCIN, which is a drug marketed by Fresenius Kabi Usa, Hikma Farmaceutica, Teva Pharms Usa, West-ward Pharms Int, and Abbott, and is included in five NDAs. It is available from five suppliers. Additional details are available on the OXYTOCIN profile page.

The generic ingredient in OXYTOCIN is oxytocin. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the oxytocin profile page.
Summary for 018248
Tradename:OXYTOCIN
Applicant:Fresenius Kabi Usa
Ingredient:oxytocin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018248
Medical Subject Heading (MeSH) Categories for 018248
Suppliers and Packaging for NDA: 018248
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYTOCIN oxytocin INJECTABLE;INJECTION 018248 NDA Cardinal Health 55154-9356 E 55154-9356-5
OXYTOCIN oxytocin INJECTABLE;INJECTION 018248 NDA Cardinal Health 55154-9577 N 55154-9577-5

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10USP UNITS/ML (10USP UNITS/ML)
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100USP UNITS/10ML (10USP UNITS/ML)
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength300USP UNITS/30ML (10USP UNITS/ML)
Approval Date:Jul 27, 2007TE:RLD:Yes

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