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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Cantor Fitzgerald

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018261

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NDA 018261 describes PITOCIN, which is a drug marketed by Par Sterile Products and is included in one NDA. It is available from one supplier. Additional details are available on the PITOCIN profile page.

The generic ingredient in PITOCIN 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 018261
Applicant:Par Sterile Products
Formulation / Manufacturing:see details
Pharmacology for NDA: 018261
Medical Subject Heading (MeSH) Categories for 018261
Suppliers and Packaging for NDA: 018261
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PITOCIN oxytocin INJECTABLE;INJECTION 018261 NDA Par Pharmaceutical, Inc. 42023-116 N 42023-116-01
PITOCIN oxytocin INJECTABLE;INJECTION 018261 NDA Par Pharmaceutical, Inc. 42023-116 N 42023-116-02

Profile for product number 001

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:Jul 27, 2007TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500USP UNITS/50ML (10USP UNITS/ML)
Approval Date:Sep 5, 2012TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Daiichi Sankyo
Queensland Health

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