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FDA ANDA · ANDA076288

RISPERIDONE

Sponsor: NATCO PHARMA USA

APPLICATION
ANDA076288
TYPE
ANDA
ORIGINAL APPROVAL
2008-09-15
LATEST ACTION
2021-10-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

RISPERIDONEDiscontinued
RISPERIDONE 4MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 2MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 0.5MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 3MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 1MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 0.25MG · TABLET · ORAL

Approval history

2021-10-01Labeling · Supplement 20 · standardAP
2020-11-03Labeling · Supplement 14 · standardAP
2020-11-03Labeling · Supplement 19 · standardAP
2020-11-03Labeling · Supplement 17 · standardAP
2020-11-03Labeling · Supplement 13 · standardAP
2020-11-03Labeling · Supplement 18 · standardAP
2016-01-05Labeling · Supplement 11 · standardAP
2013-03-21Labeling · Supplement 10 · standardAP
2012-02-13Labeling · Supplement 7AP
2011-04-22Labeling · Supplement 5AP
2010-12-29Labeling · Supplement 3AP
2010-04-27Labeling · Supplement 2AP
2008-09-15Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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