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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090839
Company: JUBILANT GENERICS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No Yes
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB 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
11/04/2011 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
09/18/2023 SUPPL-21 Labeling-Patient Package Insert

Label is not available on this site.
09/18/2023 SUPPL-19 Labeling-Package Insert

Label is not available on this site.
12/22/2019 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
12/22/2019 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
12/22/2019 SUPPL-8 Labeling

Label is not available on this site.
10/22/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
11/30/2012 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
07/24/2012 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

RISPERIDONE

TABLET, ORALLY DISINTEGRATING;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077328 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090839 JUBILANT GENERICS
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077494 PAR PHARM
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078116 SANDOZ
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077542 SUN PHARM INDS LTD
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078464 SUN PHARM INDS LTD
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078516 ZYDUS PHARMS USA

TABLET, ORALLY DISINTEGRATING;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077328 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090839 JUBILANT GENERICS
RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077494 PAR PHARM
RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078116 SANDOZ
RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077542 SUN PHARM INDS LTD
RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078464 SUN PHARM INDS LTD

TABLET, ORALLY DISINTEGRATING;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077328 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090839 JUBILANT GENERICS
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077494 PAR PHARM
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078116 SANDOZ
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077542 SUN PHARM INDS LTD
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078464 SUN PHARM INDS LTD
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078516 ZYDUS PHARMS USA

TABLET, ORALLY DISINTEGRATING;ORAL; 3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077328 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090839 JUBILANT GENERICS
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077494 PAR PHARM
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078116 SANDOZ
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078464 SUN PHARM INDS LTD
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078474 SUN PHARM INDS LTD

TABLET, ORALLY DISINTEGRATING;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077328 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090839 JUBILANT GENERICS
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077494 PAR PHARM
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078116 SANDOZ
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078464 SUN PHARM INDS LTD
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078474 SUN PHARM INDS LTD
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