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Serving leading biopharmaceutical companies globally:

Fuji
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Federal Trade Commission
Moodys
Teva
QuintilesIMS

Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205064

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NDA 205064 describes ARIPIPRAZOLE, which is a drug marketed by Alembic Pharms Ltd, Amneal Pharms, Teva Pharms Usa, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Torrent Pharms Ltd, Accord Hlthcare, Hetero Labs Ltd V, Silarx Pharms Inc, Ajanta Pharma Ltd, Santos Biotech, Apotex Inc, Orchid Hlthcare, and Sciegen Pharms Inc, and is included in nineteen NDAs. It is available from twenty-nine suppliers. Additional details are available on the ARIPIPRAZOLE profile page.

The generic ingredient in ARIPIPRAZOLE is aripiprazole. There are forty-four drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.

Summary for 205064

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 205064

Medical Subject Heading (MeSH) Categories for 205064

Suppliers and Packaging for NDA: 205064

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARIPIPRAZOLE
aripiprazole
TABLET;ORAL 205064 ANDA Camber Pharmaceuticals, Inc. 31722-819 31722-819-01 100 TABLET in 1 BOTTLE (31722-819-01)
ARIPIPRAZOLE
aripiprazole
TABLET;ORAL 205064 ANDA Camber Pharmaceuticals, Inc. 31722-819 31722-819-30 30 TABLET in 1 BOTTLE (31722-819-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Apr 28, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 28, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 28, 2015TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

US Army
Healthtrust
Deloitte
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Fish and Richardson
Queensland Health

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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