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

Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Johnson and Johnson
McKinsey
US Army
Healthtrust
Fuji
Cerilliant
McKesson
Colorcon

Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074893

« Back to Dashboard

NDA 074893 describes HALOPERIDOL DECANOATE, which is a drug marketed by Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Mylan Labs Ltd, Sandoz Inc, Teva Pharms Usa, and West-ward Pharms Int, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the HALOPERIDOL DECANOATE profile page.

The generic ingredient in HALOPERIDOL DECANOATE is haloperidol decanoate. There are twenty drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.
Summary for 074893
Tradename:HALOPERIDOL DECANOATE
Applicant:Fresenius Kabi Usa
Ingredient:haloperidol decanoate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074893
Suppliers and Packaging for NDA: 074893
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 074893 ANDA Fresenius Kabi USA, LLC 63323-469 N 63323-469-01
HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 074893 ANDA Fresenius Kabi USA, LLC 63323-469 N 63323-469-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Dec 19, 1997TE:AORLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/ML
Approval Date:Dec 19, 1997TE:AORLD:No

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Mallinckrodt
US Department of Justice
Cipla
Accenture
McKesson
AstraZeneca
Medtronic
Cantor Fitzgerald

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.