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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091384
Company: AMNEAL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription AA No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/25/2011 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/31/2021 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

10/19/2020 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

10/19/2020 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

10/19/2020 SUPPL-7 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

10/19/2020 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

10/19/2020 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

11/28/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

12/19/2012 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

01/30/2012 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

11/08/2011 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

RISPERIDONE

SOLUTION;ORAL; 1MG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISPERDAL RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription Yes AA 020588 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription No AA 091384 AMNEAL PHARMS
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription No AA 078452 AUROBINDO PHARMA LTD
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription No AA 202386 CHARTWELL MOLECULAR
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription No AA 076904 HIKMA
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription No AA 079158 LANNETT CO INC
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription No AA 077719 PHARM ASSOC
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription No AA 090347 TARO
RISPERIDONE RISPERIDONE 1MG/ML SOLUTION;ORAL Prescription No AA 079059 TRIS PHARMA INC
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