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Details for New Drug Application (NDA): 078452

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NDA 078452 describes RISPERIDONE, which is a drug marketed by Ajanta Pharma Ltd, Roxane, Vintage, Teva, Bio Pharm Inc, Sandoz, Zydus Pharms Usa, Apotex Inc, Dr Reddys Labs Ltd, Cadista Pharms, Sun Pharm Inds Inc, Mylan Pharms Inc, Jubilant Generics, Ani Pharms Inc, West Ward Pharms, Zydus Pharms Usa Inc, Sun Pharm Inds Ltd, Cipla, Wockhardt, Taro, Aurobindo Pharma, Tris Pharma Inc, Watson Labs, Pliva Hrvatska Doo, Oxford Pharms, Amneal Pharms, Ratiopharm, Silarx Pharms Inc, Synthon Pharms, Mylan, Torrent Pharms, Prinston Inc, Par Pharm, Actavis Labs Fl Inc, and Precision Dose, and is included in forty-four NDAs. It is available from sixty suppliers. Additional details are available on the RISPERIDONE profile page.

The generic ingredient in RISPERIDONE is risperidone. There are twenty-nine drug master file entries for this compound. Sixty-three suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the risperidone profile page.

Summary for NDA: 078452

Tradename:
RISPERIDONE
Applicant:
Aurobindo Pharma
Ingredient:
risperidone
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078452

Suppliers and Packaging for NDA: 078452

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERIDONE
risperidone
SOLUTION;ORAL 078452 ANDA Aurobindo Pharma Limited 65862-167 65862-167-01 1 BOTTLE in 1 CARTON (65862-167-01) > 30 mL in 1 BOTTLE
RISPERIDONE
risperidone
SOLUTION;ORAL 078452 ANDA Aurobindo Pharma Limited 65862-167 65862-167-30 1 BOTTLE, GLASS in 1 CARTON (65862-167-30) > 30 mL in 1 BOTTLE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MG/ML
Approval Date:Sep 4, 2009TE: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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