Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076228
Company: TEVA
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
06/30/2008 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/076228s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/076228s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2012 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

11/10/2011 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

06/20/2011 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

03/15/2011 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

12/29/2010 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

05/26/2010 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

02/26/2010 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/23/2009 SUPPL-2 Labeling

Label is not available on this site.

11/19/2008 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/30/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/076228s000lbl.pdf

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 076288 MYLAN
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 078071 OXFORD PHARMS
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 077769 PLIVA HRVATSKA DOO
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 076228 TEVA
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 076288 MYLAN
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 078071 OXFORD PHARMS
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 077769 PLIVA HRVATSKA DOO
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 076228 TEVA
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 076288 MYLAN
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 078071 OXFORD PHARMS
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 077769 PLIVA HRVATSKA DOO
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 076228 TEVA
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 076288 MYLAN
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 078071 OXFORD PHARMS
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 077769 PLIVA HRVATSKA DOO
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 076228 TEVA
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 076288 MYLAN
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 078071 OXFORD PHARMS
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 077769 PLIVA HRVATSKA DOO
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 076228 TEVA
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 076288 MYLAN
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 078071 OXFORD PHARMS
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 077769 PLIVA HRVATSKA DOO
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 076228 TEVA
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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