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Serving leading biopharmaceutical companies globally:

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Chinese Patent Office
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Generated: December 18, 2017

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

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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 42023-116-02 25 VIAL in 1 CARTON (42023-116-02) > 10 mL in 1 VIAL
PITOCIN oxytocin INJECTABLE;INJECTION 018261 NDA Par Pharmaceutical, Inc. 42023-116 42023-116-01 1 VIAL in 1 CARTON (42023-116-01) > 10 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:Jul 27, 2007TE:APRLD:Yes

Summary 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 leading biopharmaceutical companies globally:

US Department of Justice
McKinsey
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Citi
McKesson
Teva
Deloitte
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Cantor Fitzgerald
UBS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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