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Details for New Drug Application (NDA): 018248

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NDA 018248 describes OXYTOCIN, which is a drug marketed by Hikma Farmaceutica, West-ward Pharms Int, Fresenius Kabi Usa, Teva Pharms Usa, 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. Eight suppliers are listed for this compound. Additional details are available on the oxytocin profile page.

Summary for NDA: 018248

Tradename:
OXYTOCIN
Applicant:
Fresenius Kabi Usa
Ingredient:
oxytocin
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 55154-9356-5 5 VIAL in 1 BAG (55154-9356-5) > 1 mL in 1 VIAL
OXYTOCIN
oxytocin
INJECTABLE;INJECTION 018248 NDA APP Pharmaceuticals, LLC 63323-012 63323-012-01 25 VIAL in 1 TRAY (63323-012-01) > 1 mL in 1 VIAL

Summary 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

Summary 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

Summary 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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