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Serving leading biopharmaceutical companies globally:

Colorcon
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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018701

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NDA 018701 describes HALDOL, which is a drug marketed by Ortho Mcneil, Janssen Pharms, and Ortho Mcneil Pharm, and is included in five NDAs. It is available from three suppliers. Additional details are available on the HALDOL profile page.

The generic ingredient in HALDOL is haloperidol. There are twenty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the haloperidol profile page.

Summary for 018701

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 018701

Medical Subject Heading (MeSH) Categories for 018701

Suppliers and Packaging for NDA: 018701

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALDOL haloperidol decanoate INJECTABLE;INJECTION 018701 NDA AUTHORIZED GENERIC Patriot Pharmaceuticals LLC 10147-0921 10147-0921-3 3 AMPULE in 1 BOX (10147-0921-3) > 1 mL in 1 AMPULE
HALDOL haloperidol decanoate INJECTABLE;INJECTION 018701 NDA AUTHORIZED GENERIC Patriot Pharmaceuticals LLC 10147-0922 10147-0922-5 5 AMPULE in 1 BOX (10147-0922-5) > 1 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Jan 14, 1986TE:AORLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/ML
Approval Date:Jan 31, 1997TE:AORLD:Yes


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Serving leading biopharmaceutical companies globally:

US Department of Justice
Julphar
Medtronic
Johnson and Johnson
Daiichi Sankyo
Citi
Teva
Mallinckrodt
Accenture
US Army

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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