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Serving 500+ biopharmaceutical companies globally:

Cerilliant
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Generated: July 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078347

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NDA 078347 describes HALOPERIDOL, which is a drug marketed by Solopak, Smith And Nephew, Sandoz, Morton Grove, Frontida Biopharm, Watson Labs, Teva, Marsam Pharms Llc, Duramed Pharms Barr, Teva Pharms, Alpharma, SCS, Royce Labs, Lederle, Claris, Cycle Pharms Ltd, Par Pharm, Teva Pharms Usa, Vintage, Pharm Assoc, Sagent Pharms, Mylan Labs Ltd, Quantum Pharmics, West-ward Pharms Int, Silarx, Sandoz Inc, Purepac Pharm, Gland Pharma Ltd, Mylan, Zydus Pharms Usa, Abraxis Pharm, Fresenius Kabi Usa, Hospira, and Actavis Mid Atlantic, and is included in one hundred and five NDAs. It is available from thirty-four suppliers. Additional details are available on the HALOPERIDOL profile page.

The generic ingredient in HALOPERIDOL 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 NDA: 078347

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 078347

Suppliers and Packaging for NDA: 078347

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALOPERIDOL
haloperidol lactate
 INJECTABLE;INJECTION 078347 ANDA Pfizer Laboratories Div Pfizer Inc 0069-0113 0069-0113-02 25 VIAL in 1 CARTON (0069-0113-02) > 1 mL in 1 VIAL (0069-0113-01)
HALOPERIDOL
haloperidol lactate
 INJECTABLE;INJECTION 078347 ANDA General Injectables and Vaccines, Inc. 52584-426 52584-426-00 1 VIAL in 1 BAG (52584-426-00) > 1 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Sep 14, 2009TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Chubb
Queensland Health
AstraZeneca
Argus Health
Citi
Mallinckrodt
Cipla
Cantor Fitzgerald
Novartis
Covington

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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