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FDA Drug information

Risperidone

Read time: 1 mins
Marketing start date: 28 Apr 2024
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Summary of product characteristics


Effective Time

20221014

Version

10

Spl Product Data Elements

risperidone risperidone RISPERIDONE RISPERIDONE ASPARTAME CALCIUM STEARATE CROSPOVIDONE (15 MPA.S AT 5%) MANNITOL PEPPERMINT SODIUM LAURYL SULFATE DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER WHITE TO OFF-WHITE FLAVOR FIRMENICH POWDER PEPPERMINT ROUND ZD;22 risperidone risperidone RISPERIDONE RISPERIDONE ASPARTAME CALCIUM STEARATE CROSPOVIDONE (15 MPA.S AT 5%) MANNITOL PEPPERMINT SODIUM LAURYL SULFATE DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER WHITE TO OFF-WHITE FLAVOR FIRMENICH POWDER PEPPERMINT ROUND ZD;21 risperidone risperidone RISPERIDONE RISPERIDONE ASPARTAME CALCIUM STEARATE CROSPOVIDONE (15 MPA.S AT 5%) MANNITOL PEPPERMINT SODIUM LAURYL SULFATE DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER WHITE TO OFF-WHITE FLAVOR FIRMENICH POWDER PEPPERMINT ROUND ZD;20

Application Number

ANDA078516

Brand Name

Risperidone

Generic Name

risperidone

Product Ndc

65841-641

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-640-06 in bottle of 30 tablets Risperidone Orally Disintegrating Tablets, 0.5 mg Rx only 30 tablets NDC 65841-641-06 in bottle of 30 tablets Risperidone Orally Disintegrating Tablets, 1 mg Rx only 30 tablets NDC 65841-642-06 in bottle of 30 tablets Risperidone Orally Disintegrating Tablets, 2 mg Rx only 30 tablets Risperidone Orally Disintegrating Tablets Risperidone Orally Disintegrating Tablets Risperidone Orally Disintegrating Tablets

Drug section

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