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FDA Drug information

Risperidone

Read time: 1 mins
Marketing start date: 02 May 2024
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Summary of product characteristics


Effective Time

20221031

Version

8

Spl Product Data Elements

risperidone risperidone RISPERIDONE RISPERIDONE FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE PROPYLENE GLYCOL SODIUM LAURYL SULFATE TITANIUM DIOXIDE FERRIC OXIDE RED CELLULOSE, MICROCRYSTALLINE STARCH, CORN DARK YELLOW ROUND Z;4 risperidone risperidone RISPERIDONE RISPERIDONE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE PROPYLENE GLYCOL SODIUM LAURYL SULFATE TITANIUM DIOXIDE FERRIC OXIDE RED CELLULOSE, MICROCRYSTALLINE STARCH, CORN RED BROWN ROUND Z;6 risperidone risperidone RISPERIDONE RISPERIDONE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE PROPYLENE GLYCOL SODIUM LAURYL SULFATE TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE STARCH, CORN WHITE TO OFF-WHITE ROUND ZC;75 risperidone risperidone RISPERIDONE RISPERIDONE FD&C YELLOW NO. 6 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE PROPYLENE GLYCOL SODIUM LAURYL SULFATE TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE STARCH, CORN ORANGE ROUND ZC;76 risperidone risperidone RISPERIDONE RISPERIDONE D&C YELLOW NO. 10 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE PROPYLENE GLYCOL SODIUM LAURYL SULFATE TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE STARCH, CORN YELLOW ROUND ZC;77 risperidone risperidone RISPERIDONE RISPERIDONE D&C YELLOW NO. 10 FD&C BLUE NO. 2 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE PROPYLENE GLYCOL SODIUM LAURYL SULFATE TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE STARCH, CORN GREEN ROUND ZC;78

Application Number

ANDA078040

Brand Name

Risperidone

Generic Name

risperidone

Product Ndc

65841-665

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Risperidone Tablets USP, 0.25 mg NDC 65841-665-14 60 tablets Rx only Risperidone Tablets USP, 0.5 mg NDC 65841-666-14 60 tablets Rx only Risperidone Tablets USP, 1 mg NDC 65841-667-14 60 Tablets Rx only Risperidone Tablets USP, 2 mg NDC 65841-668-14 60 Tablets Rx only Risperidone Tablets USP, 3 mg NDC 65841-669-14 60 Tablets Rx only Risperidone Tablets USP, 4 mg NDC 65841-670-14 60 Tablets Rx only image image image image image image

Drug section

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