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Details for New Drug Application (NDA): 204094

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NDA 204094 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, Hetero Labs Ltd V, Silarx Pharms Inc, Ajanta Pharma Ltd, Apotex Inc, and Sciegen Pharms Inc, and is included in sixteen NDAs. It is available from twenty-four suppliers. Additional details are available on the ARIPIPRAZOLE profile page.

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

Summary for NDA: 204094

Tradename:
ARIPIPRAZOLE
Applicant:
Apotex Inc
Ingredient:
aripiprazole
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204094

Suppliers and Packaging for NDA: 204094

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARIPIPRAZOLE
aripiprazole
SOLUTION;ORAL 204094 ANDA Apotex Corp. 60505-0404 60505-0404-5 1 BOTTLE in 1 CARTON (60505-0404-5) > 150 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MG/ML
Approval Date:Sep 30, 2015TE:AARLD:No


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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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