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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Citi
Deloitte
Medtronic
Cantor Fitzgerald
Boehringer Ingelheim
Julphar
Colorcon
Fuji

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016812

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NDA 016812 describes KETALAR, which is a drug marketed by Par Sterile Products and is included in one NDA. It is available from two suppliers. Additional details are available on the KETALAR profile page.

The generic ingredient in KETALAR is ketamine hydrochloride. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ketamine hydrochloride profile page.
Summary for 016812
Tradename:KETALAR
Applicant:Par Sterile Products
Ingredient:ketamine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 016812
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for 016812
Suppliers and Packaging for NDA: 016812
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETALAR ketamine hydrochloride INJECTABLE;INJECTION 016812 NDA Par Pharmaceutical, Inc. 42023-113 N 42023-113-10
KETALAR ketamine hydrochloride INJECTABLE;INJECTION 016812 NDA Par Pharmaceutical, Inc. 42023-114 N 42023-114-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
McKinsey
Daiichi Sankyo
Argus Health
Merck
Dow
Fish and Richardson
Chinese Patent Office
Queensland Health

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