Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076908
Company: TEVA
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 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
03/12/2012 ORIG-1 Approval

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; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISPERDAL RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021444 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076996 ACTAVIS LABS FL INC
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
RISPERIDONE RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076908 TEVA

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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