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Cipla
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US Army
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Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018243

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NDA 018243 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 three 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. Four suppliers are listed for this compound. Additional details are available on the oxytocin profile page.
Summary for 018243
Tradename:OXYTOCIN
Applicant:West-ward Pharms Int
Ingredient:oxytocin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018243
Medical Subject Heading (MeSH) Categories for 018243
Suppliers and Packaging for NDA: 018243
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYTOCIN oxytocin INJECTABLE;INJECTION 018243 NDA West-Ward Pharmaceutical Corp. 0641-6114 N 0641-6114-25
OXYTOCIN oxytocin INJECTABLE;INJECTION 018243 NDA West-Ward Pharmaceutical Corp. 0641-6115 N 0641-6115-25

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:Jan 10, 2007TE:APRLD:Yes

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