Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020272
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RISPERDAL RISPERIDONE 1MG TABLET;ORAL Prescription AB Yes Yes
RISPERDAL RISPERIDONE 2MG TABLET;ORAL Prescription AB Yes No
RISPERDAL RISPERIDONE 3MG TABLET;ORAL Prescription AB Yes No
RISPERDAL RISPERIDONE 4MG TABLET;ORAL Prescription AB Yes No
RISPERDAL RISPERIDONE 5MG TABLET;ORAL Discontinued None No No
RISPERDAL RISPERIDONE 0.5MG TABLET;ORAL Prescription AB Yes No
RISPERDAL RISPERIDONE 0.25MG TABLET;ORAL Prescription AB Yes 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
12/29/1993 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020272_safety_review.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/2017 SUPPL-78 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020272s078,020588s066,021444s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020272Orig1s078,020588Orig1s066,021444Orig1s052,021346Orig1s056ltr.pdf
03/01/2016 SUPPL-77 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020272s077,020588s065,021346s055,021444s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf
02/09/2016 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

04/28/2014 SUPPL-73 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020272s073,020588s062,021444s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020272Orig1s073,020588Orig1s062,021444Orig1s048,021346Orig1s051ltr.pdf
06/13/2013 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

02/08/2013 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

03/12/2012 SUPPL-67 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272s067,020588s055,021444s043,021346s044ltr.pdf
09/24/2011 SUPPL-66 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444s042,s035,020588s054,s048ltr.pdf
08/02/2012 SUPPL-65 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020272s065,020588s053,021444s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272Orig1s065,020588Orig1s053,021444Orig1s041ltr.pdf
06/15/2011 SUPPL-64 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s064,020588s052,021444s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s064,020588s052,021444s040,021346s042ltr.pdf
12/01/2010 SUPPL-63 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s063,020588s051,021346s040,021444s039ltr.pdf
08/30/2010 SUPPL-62 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf
08/30/2010 SUPPL-61 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf
09/24/2011 SUPPL-60 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444s042,s035,020588s054,s048ltr.pdf
08/24/2011 SUPPL-59 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s059,020588s047,021444s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s059,020588s047,021444s034,021346s036ltr.pdf
08/30/2010 SUPPL-58 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf
07/19/2009 SUPPL-56 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020272s056,020588s044,021346s033,021444s031ltr.pdf
08/30/2010 SUPPL-55 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf
08/14/2008 SUPPL-54 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020272s054,020588s042,021346s027,021444s029ltr.pdf
08/22/2007 SUPPL-47 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s37,21444s20s21ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020272_s046_risperdal_toc.cfm
08/22/2007 SUPPL-46 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s37,21444s20s21ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020272_s046_risperdal_toc.cfm
08/17/2005 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020272s042,020588s030,021444s016,021346s010ltr.pdf
10/06/2006 SUPPL-41 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020272Orig1s036,s041,020588Orig1s024,s028,s029,21444Orig1s008,s015.pdf
10/06/2006 SUPPL-36 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020272Orig1s036,s041,020588Orig1s024,s028,s029,21444Orig1s008,s015.pdf
11/21/2003 SUPPL-35 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr035,20588slr023,21444slr007ltr.pdf
09/10/2003 SUPPL-33 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21444slr004,20588slr021,20272slr033ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020272_S033_RISPERDAL_TABLETS.pdf
12/04/2003 SUPPL-27 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272se1-26,27,20588se1-017,018,21444se1-002,003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020272_s026&s027_Risperdal_MEDR_.pdf
12/04/2003 SUPPL-26 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272se1-26,27,20588se1-017,018,21444se1-002,003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020272_s026&s027_Risperdal_MEDR_.pdf
10/29/2003 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr025,20588slr016,21444slr005ltr.pdf
11/19/2002 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20272slr024,20588slr015ltr.pdf
07/09/2002 SUPPL-23 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/28/2001 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/22/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/2001 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/27/1999 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/10/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/27/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/26/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/13/1998 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/02/1999 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20588s05lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20588s05ltr.pdf
03/03/2002 SUPPL-8 Efficacy-Labeling Change With Clinical Data Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20272s8ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020272_s008_RISPERDALE TABLETS.pdf
10/17/1997 SUPPL-7 Efficacy-New Dosing Regimen Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20588.pdf
04/02/1998 SUPPL-6 Labeling

Label is not available on this site.

03/07/1996 SUPPL-5 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020272_S004_RISPERDAL TABLETS.pdf
02/28/1996 SUPPL-4 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020272_S004_RISPERDAL TABLETS.pdf
04/12/1995 SUPPL-3 Labeling

Label is not available on this site.

12/22/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/24/1994 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
02/23/2017 SUPPL-78 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020272s078,020588s066,021444s052lbl.pdf
03/01/2016 SUPPL-77 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020272s077,020588s065,021346s055,021444s051lbl.pdf
04/28/2014 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020272s073,020588s062,021444s048lbl.pdf
08/02/2012 SUPPL-65 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020272s065,020588s053,021444s041lbl.pdf
09/24/2011 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf
09/24/2011 SUPPL-60 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf
08/24/2011 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s059,020588s047,021444s034lbl.pdf
06/15/2011 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s064,020588s052,021444s040lbl.pdf
12/01/2010 SUPPL-63 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf
08/30/2010 SUPPL-62 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf
08/30/2010 SUPPL-61 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf
08/30/2010 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf
08/30/2010 SUPPL-55 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf
07/19/2009 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf
08/22/2007 SUPPL-47 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf
08/22/2007 SUPPL-46 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf
10/06/2006 SUPPL-41 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf
10/06/2006 SUPPL-36 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf
08/17/2005 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf
12/04/2003 SUPPL-27 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf
12/04/2003 SUPPL-26 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf
07/02/1999 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20588s05lbl.pdf

RISPERDAL

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 AUROBINDO PHARMA
RISPERIDONE RISPERIDONE 1MG TABLET;ORAL Prescription No AB 077543 CIPLA
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 PRINSTON INC
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 AUROBINDO PHARMA
RISPERIDONE RISPERIDONE 2MG TABLET;ORAL Prescription No AB 077543 CIPLA
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 PRINSTON INC
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 AUROBINDO PHARMA
RISPERIDONE RISPERIDONE 3MG TABLET;ORAL Prescription No AB 077543 CIPLA
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 PRINSTON INC
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 AUROBINDO PHARMA
RISPERIDONE RISPERIDONE 4MG TABLET;ORAL Prescription No AB 077543 CIPLA
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 PRINSTON INC
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

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 AUROBINDO PHARMA
RISPERIDONE RISPERIDONE 0.5MG TABLET;ORAL Prescription No AB 077543 CIPLA
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 PRINSTON INC
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; 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 AUROBINDO PHARMA
RISPERIDONE RISPERIDONE 0.25MG TABLET;ORAL Prescription No AB 077543 CIPLA
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 PRINSTON INC
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

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