.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018261

« Back to Dashboard
NDA 018261 describes PITOCIN, which is a drug marketed by Par Sterile Products and is included in one NDA. It is available from three suppliers. 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. Eight suppliers are listed for this compound. Additional details are available on the oxytocin profile page.

Summary for NDA: 018261

Tradename:
PITOCIN
Applicant:
Par Sterile Products
Ingredient:
oxytocin
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 42023-116-01 1 VIAL in 1 CARTON (42023-116-01) > 10 mL in 1 VIAL
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

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:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500USP UNITS/50ML (10USP UNITS/ML)
Approval Date:Sep 5, 2012TE:RLD:No


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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.

`abc