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Generated: July 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070278

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NDA 070278 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: 070278

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

Pharmacology for NDA: 070278

Suppliers and Packaging for NDA: 070278

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALOPERIDOL
haloperidol
TABLET;ORAL 070278 ANDA Mylan Pharmaceuticals Inc. 0378-0214 0378-0214-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0214-01)
HALOPERIDOL
haloperidol
TABLET;ORAL 070278 ANDA Mylan Pharmaceuticals Inc. 0378-0214 0378-0214-10 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0214-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jun 10, 1986TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 16, 2009TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jul 16, 2009TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Citi
McKinsey
Mallinckrodt
Dow
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Farmers Insurance
AstraZeneca
Cantor Fitzgerald
Covington
Merck

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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