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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 214068


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NDA 214068 describes RISPERIDONE, which is a drug marketed by Teva Pharms Usa Inc, Amneal Pharms, Ani Pharms, Aurobindo Pharma Ltd, Chartwell Molecular, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Sciegen Pharms Inc, Taro, Tris Pharma Inc, Wockhardt, Actavis Labs Fl Inc, Chartwell Rx, Dash Pharms, Dr Reddys Labs Ltd, Endo Operations, Jubilant Generics, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Amneal, Apotex Inc, Heritage Pharma Avet, Ipca Labs Ltd, Jubilant Cadista, Novitium Pharma, Prinston Inc, Ratiopharm, Renata, Rising, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in forty-six NDAs. It is available from thirty-two 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 214068
Tradename:RISPERIDONE
Applicant:Teva Pharms Usa Inc
Ingredient:risperidone
Patents:0
Medical Subject Heading (MeSH) Categories for 214068
Suppliers and Packaging for NDA: 214068
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERIDONE risperidone INJECTABLE;INTRAMUSCULAR 214068 ANDA Teva Pharmaceuticals, Inc. 0480-1232 0480-1232-08 1 KIT in 1 CARTON (0480-1232-08) * 2 mL in 1 VIAL (0480-9733-01) * 2 mL in 1 SYRINGE (0480-1200-21)
RISPERIDONE risperidone INJECTABLE;INTRAMUSCULAR 214068 ANDA Teva Pharmaceuticals, Inc. 0480-1342 0480-1342-08 1 KIT in 1 CARTON (0480-1342-08) * 2 mL in 1 VIAL (0480-9734-01) * 2 mL in 1 SYRINGE (0480-1200-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULARStrength12.5MG/VIAL
Approval Date:Dec 5, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULARStrength25MG/VIAL
Approval Date:Dec 5, 2023TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULARStrength37.5MG/VIAL
Approval Date:Dec 5, 2023TE:ABRLD:No

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