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Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078871

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NDA 078871 describes RISPERIDONE, which is a drug marketed by Ajanta Pharma Ltd, West-ward Pharms Int, Prinston Inc, Teva, Bio Pharm Inc, Sandoz, Zydus Pharms Usa, Apotex Inc, Dr Reddys Labs Ltd, Jubilant Cadista, 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, Lifestar Pharma, Vintage, Tris Pharma Inc, Watson Labs, Aurobindo Pharma, Pliva Hrvatska Doo, Oxford Pharms, Amneal Pharms, Ratiopharm, Silarx Pharms Inc, Synthon Pharms, Mylan, Torrent Pharms, Par Pharm, Actavis Labs Fl Inc, and Precision Dose, and is included in forty-four NDAs. It is available from fifty-seven 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-nine suppliers are listed for this compound. Additional details are available on the risperidone profile page.

Summary for NDA: 078871

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

Pharmacology for NDA: 078871

Suppliers and Packaging for NDA: 078871

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERIDONE
risperidone
TABLET;ORAL 078871 ANDA DOH CENTRAL PHARMACY 53808-0565 53808-0565-1 30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0565-1)
RISPERIDONE
risperidone
TABLET;ORAL 078871 ANDA WOCKHARDT LIMITED 55648-553 55648-553-01 30 TABLET, FILM COATED in 1 BOTTLE (55648-553-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Oct 9, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Oct 9, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Oct 9, 2008TE:ABRLD:No


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