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Details for New Drug Application (NDA): 078871

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NDA 078871 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: 078871

Therapeutic Class:Antipsychotics
Bipolar Agents

Pharmacology for NDA: 078871

Suppliers and Packaging for NDA: 078871

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 078871 ANDA WOCKHARDT LIMITED 55648-553 55648-553-01 30 TABLET, FILM COATED in 1 BOTTLE (55648-553-01)
TABLET;ORAL 078871 ANDA WOCKHARDT LIMITED 55648-553 55648-553-02 500 TABLET, FILM COATED in 1 BOTTLE (55648-553-02)

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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