Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078516
Company: ZYDUS PHARMS USA
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 2MG 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
05/01/2009 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
11/02/2014 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

04/16/2013 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

04/30/2012 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

07/25/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

07/11/2011 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

06/10/2011 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

12/29/2010 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

11/06/2009 SUPPL-1 Labeling-Container/Carton Labels

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
RISPERDAL RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021444 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076996 ACTAVIS LABS FL INC
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 076908 TEVA
RISPERIDONE RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078516 ZYDUS PHARMS USA

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISPERDAL RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021444 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076996 ACTAVIS LABS FL INC
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 076908 TEVA
RISPERIDONE RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078516 ZYDUS PHARMS USA

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