Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021444
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RISPERDAL RISPERIDONE 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB Yes No
RISPERDAL RISPERIDONE 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB Yes Yes
RISPERDAL RISPERIDONE 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB Yes No
RISPERDAL RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB Yes No
RISPERDAL RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;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
04/02/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021444lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21444ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021444_risperdal.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/25/2019 SUPPL-56 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020272s082,020588s070,021444s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020272Orig1s082,020588Orig1s070,021444Orig1s056,021346Orig1s060Ltr.pdf
07/27/2018 SUPPL-54 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020272s080,020588s068,021444s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020272Orig1s080,020588Orig1s068,021444Orig1s054,021346Orig1s058ltr.pdf
02/23/2017 SUPPL-52 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-51 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
04/28/2014 SUPPL-48 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
03/12/2012 SUPPL-43 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-42 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-41 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-40 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-39 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-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf
08/30/2010 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf
09/24/2011 SUPPL-35 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-34 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-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf
07/19/2009 SUPPL-31 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-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf
08/14/2008 SUPPL-29 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-21 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-20 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-16 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-15 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
12/23/2004 SUPPL-12 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21444s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21444s012ltr.pdf
10/06/2006 SUPPL-8 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-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr035,20588slr023,21444slr007ltr.pdf
10/29/2003 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr025,20588slr016,21444slr005ltr.pdf
09/10/2003 SUPPL-4 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/2003/021444_S004_RISPERDAL_TABLETS.pdf
12/04/2003 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (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
12/04/2003 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/25/2019 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020272s082,020588s070,021444s056lbl.pdf
07/27/2018 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020272s080,020588s068,021444s054lbl.pdf
02/23/2017 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020272s078,020588s066,021444s052lbl.pdf
03/01/2016 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020272s077,020588s065,021346s055,021444s051lbl.pdf
04/28/2014 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020272s073,020588s062,021444s048lbl.pdf
08/02/2012 SUPPL-41 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-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf
09/24/2011 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf
08/24/2011 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s059,020588s047,021444s034lbl.pdf
06/15/2011 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s064,020588s052,021444s040lbl.pdf
12/01/2010 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf
08/30/2010 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf
08/30/2010 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf
08/30/2010 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf
08/30/2010 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf
07/19/2009 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf
08/22/2007 SUPPL-21 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf
08/22/2007 SUPPL-20 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf
10/06/2006 SUPPL-15 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf
10/06/2006 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf
08/17/2005 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf
12/23/2004 SUPPL-12 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21444s012lbl.pdf
12/04/2003 SUPPL-3 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-2 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
04/02/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021444lbl.pdf

RISPERDAL

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

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021444 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076996 ACTAVIS LABS FL INC
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077328 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090839 JUBILANT GENERICS
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077494 PAR PHARM
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078116 SANDOZ
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078464 SUN PHARM INDS LTD
RISPERIDONE RISPERIDONE 3MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078474 SUN PHARM INDS LTD

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021444 JANSSEN PHARMS
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076996 ACTAVIS LABS FL INC
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077328 DR REDDYS LABS LTD
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090839 JUBILANT GENERICS
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077494 PAR PHARM
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078116 SANDOZ
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078464 SUN PHARM INDS LTD
RISPERIDONE RISPERIDONE 4MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078474 SUN PHARM INDS LTD

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