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FDA ANDA · ANDA076440

RISPERIDONE

Sponsor: ANI PHARMS

APPLICATION
ANDA076440
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-30
LATEST ACTION
2024-07-14
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

RISPERIDONEPrescription
RISPERIDONE 1MG/ML · SOLUTION · ORAL

Approval history

2024-07-14Labeling · Supplement 8 · standardAP
2024-07-14Labeling · Supplement 6 · standardAP
2024-07-14Labeling · Supplement 7 · standardAP
2011-09-27Labeling · Supplement 5AP
2011-01-11Labeling · Supplement 3AP
2010-04-27Labeling · Supplement 2AP
2009-12-15Labeling · Supplement 1AP
2009-01-30Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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