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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078269

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NDA 078269 describes RISPERIDONE, which is a drug marketed by Amneal Pharms, Ani Pharms Inc, Apotex Inc, Bio Pharm Inc, Lifestar Pharma, Precision Dose, Silarx Pharms Inc, Taro, Tris Pharma Inc, Vintage, West-ward Pharms Int, Wockhardt, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Jubilant Generics, Mylan Pharms Inc, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Teva, Zydus Pharms Usa, Ajanta Pharma Ltd, Aurobindo Pharma, Cipla, Jubilant Cadista, Mylan, Oxford Pharms, Pliva Hrvatska Doo, Prinston Inc, Ratiopharm, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in forty-four NDAs. It is available from fifty-six suppliers. Additional details are available on the RISPERIDONE profile page.

The generic ingredient in RISPERIDONE is risperidone. There are thirty drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the risperidone profile page.

Summary for 078269

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

Pharmacology for NDA: 078269

Medical Subject Heading (MeSH) Categories for 078269

Suppliers and Packaging for NDA: 078269

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERIDONE risperidone TABLET;ORAL 078269 ANDA Aurolife Pharma LLC 13107-119 13107-119-60 60 TABLET, FILM COATED in 1 BOTTLE (13107-119-60)
RISPERIDONE risperidone TABLET;ORAL 078269 ANDA Aurolife Pharma LLC 13107-119 13107-119-10 10 BLISTER PACK in 1 CARTON (13107-119-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Oct 8, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Oct 8, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Oct 8, 2008TE:ABRLD:No


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