Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076288
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription AB No No
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription AB No No
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription AB No No
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription AB No No
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription AB No No
RISPERIDONE RISPERIDONE 4MG TABLET;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
09/15/2008 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
01/05/2016 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

03/21/2013 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

02/13/2012 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/22/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

12/29/2010 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

04/27/2010 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

RISPERIDONE

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISPERDAL RISPERIDONE 0.25MG TABLET;ORAL Prescription Yes AB 020272 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 201003 AJANTA PHARMA LTD
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 077953 APOTEX INC
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 078269 CEYONE
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 077543 CHARTWELL MOLECULAR
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 076879 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 076228 HERITAGE PHARMA
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 077769 HERITAGE PHARMA
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 076288 MYLAN
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 078071 OXFORD PHARMS
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 077493 PRINSTON INC
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 078707 RENATA
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 078528 SANDOZ
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 078036 SUN PHARM INDS INC
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 079088 TORRENT PHARMS
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 078871 WOCKHARDT
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 078040 ZYDUS PHARMS USA INC

TABLET;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;ORAL Prescription Yes AB 020272 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 201003 AJANTA PHARMA LTD
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 077953 APOTEX INC
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 078269 CEYONE
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 077543 CHARTWELL MOLECULAR
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 076879 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 076228 HERITAGE PHARMA
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 077769 HERITAGE PHARMA
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 076288 MYLAN
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 078071 OXFORD PHARMS
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 077493 PRINSTON INC
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 078707 RENATA
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 078528 SANDOZ
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 078036 SUN PHARM INDS INC
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 079088 TORRENT PHARMS
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 078871 WOCKHARDT
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 078040 ZYDUS PHARMS USA INC

TABLET;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;ORAL Prescription Yes AB 020272 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 201003 AJANTA PHARMA LTD
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 077953 APOTEX INC
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 078269 CEYONE
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 077543 CHARTWELL MOLECULAR
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 076879 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 076228 HERITAGE PHARMA
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 077769 HERITAGE PHARMA
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 076288 MYLAN
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 078071 OXFORD PHARMS
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 077493 PRINSTON INC
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 078707 RENATA
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 078528 SANDOZ
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 078036 SUN PHARM INDS INC
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 079088 TORRENT PHARMS
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 078871 WOCKHARDT
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 078040 ZYDUS PHARMS USA INC

TABLET;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;ORAL Prescription Yes AB 020272 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 201003 AJANTA PHARMA LTD
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 077953 APOTEX INC
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 078269 CEYONE
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 077543 CHARTWELL MOLECULAR
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 076879 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 076228 HERITAGE PHARMA
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 077769 HERITAGE PHARMA
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 076288 MYLAN
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 078071 OXFORD PHARMS
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 077493 PRINSTON INC
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 078707 RENATA
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 078528 SANDOZ
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 078036 SUN PHARM INDS INC
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 079088 TORRENT PHARMS
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 078871 WOCKHARDT
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 078040 ZYDUS PHARMS USA INC

TABLET;ORAL; 3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISPERDAL RISPERIDONE 3MG TABLET;ORAL Prescription Yes AB 020272 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 201003 AJANTA PHARMA LTD
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 077953 APOTEX INC
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 078269 CEYONE
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 077543 CHARTWELL MOLECULAR
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 076879 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 076228 HERITAGE PHARMA
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 077769 HERITAGE PHARMA
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 076288 MYLAN
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 078071 OXFORD PHARMS
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 077493 PRINSTON INC
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 078707 RENATA
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 078528 SANDOZ
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 078036 SUN PHARM INDS INC
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 079088 TORRENT PHARMS
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 078871 WOCKHARDT
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 078040 ZYDUS PHARMS USA INC

TABLET;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RISPERDAL RISPERIDONE 4MG TABLET;ORAL Prescription Yes AB 020272 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 201003 AJANTA PHARMA LTD
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 077953 APOTEX INC
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 078269 CEYONE
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 077543 CHARTWELL MOLECULAR
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 076879 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 076228 HERITAGE PHARMA
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 077769 HERITAGE PHARMA
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 076288 MYLAN
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 078071 OXFORD PHARMS
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 077493 PRINSTON INC
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 078707 RENATA
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 078528 SANDOZ
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 078036 SUN PHARM INDS INC
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 079088 TORRENT PHARMS
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 078871 WOCKHARDT
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 078040 ZYDUS PHARMS USA INC

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