Risperidone Disintegrating Oral Tablet

Brand(s)
Risperdal
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Pharmaceuticals, Inc. (2014-05-12)
Oldest Current Product
2003-04-02
License(s)
NDA, ANDA
RxNORM
DISINTEGRATING ORAL TABLET\RISPERIDONE
FDAOB
ORAL\TABLET, ORALLY DISINTEGRATING\RISPERIDONE
SPL Active
ORAL\TABLET, ORALLY DISINTEGRATING\RISPERIDONE
SPL Moiety
ORAL\TABLET, ORALLY DISINTEGRATING\RISPERIDONE

product(s) by strength(s)

risperidone 0.25 mg disintegrating oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003786042ANDAMylan Pharmaceuticals Inc.2013-03-11RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA0915375958bb43-6967-4f15-9bd1-7f06340527ff
2498840212ANDAPar Pharmaceutical Companies, Inc.2009-06-01RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA077494d0ef6df3-67e5-47b1-bcf7-f67aa030caca

risperidone 0.5 mg disintegrating oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580601NDAJanssen Pharmaceuticals, Inc.2003-04-02RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGNDA021444701e1cd8-2868-4d29-85a9-a2212c88165f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003786043ANDAMylan Pharmaceuticals Inc.2011-05-11RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA0915375958bb43-6967-4f15-9bd1-7f06340527ff
2007815310ANDASandoz Inc2009-12-22RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA078116e5ec2af6-7777-4dc2-9cea-eefc2629d5ad
3498840311ANDAPar Pharmaceutical Companies, Inc.2009-06-01RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA077494d0ef6df3-67e5-47b1-bcf7-f67aa030caca
4551110207ANDADr. Reddy'S Laboratories Ltd2009-02-24RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA077328c00809e1-e632-f246-97d9-73e1f9804587
5597460010ANDAJubilant Cadista Pharmaceuticals, Inc.2010-12-01RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA090839739dcf8a-ed73-5eb0-899b-7e51cb73c335
6627560700ANDASun Pharmaceutical Industries Limited2013-04-13RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA07846414603eab-6683-4c2a-b9fc-263142af5651
7633040949ANDARnabaxy Pharmaceuticals Inc.2010-08-06RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA077542f91f551e-926f-440d-83d2-357e9d7484fe
8658410640ANDACadila Healthcare Limited2010-06-29RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA0785161522f0b9-2bbc-4785-bada-fa6ae7986bb4
9683820154ANDAZydus Pharmaceuticals (Usa) Inc.2010-06-29RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA0785162c62c65f-527e-44ed-8491-30db3eb8b902

risperidone 1 mg disintegrating oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580602NDAJanssen Pharmaceuticals, Inc.2003-04-02RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGNDA021444701e1cd8-2868-4d29-85a9-a2212c88165f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003786044ANDAMylan Pharmaceuticals Inc.2011-05-11RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA0915375958bb43-6967-4f15-9bd1-7f06340527ff
2007815311ANDASandoz Inc2009-12-22RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA078116e5ec2af6-7777-4dc2-9cea-eefc2629d5ad
3498840315ANDAPar Pharmaceutical Companies, Inc.2009-10-26RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA077494d0ef6df3-67e5-47b1-bcf7-f67aa030caca
4551110208ANDADr. Reddy'S Laboratories Ltd2009-10-06RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA077328c00809e1-e632-f246-97d9-73e1f9804587
5597460020ANDAJubilant Cadista Pharmaceuticals, Inc.2010-12-01RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA090839739dcf8a-ed73-5eb0-899b-7e51cb73c335
6627560701ANDASun Pharmaceutical Industries Limited2013-04-13RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA07846414603eab-6683-4c2a-b9fc-263142af5651
7633040950ANDARnabaxy Pharmaceuticals Inc.2010-08-06RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA077542f91f551e-926f-440d-83d2-357e9d7484fe

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1510790345ANDAMylan Institutional Inc.2011-06-10RISPERIDONEORALTABLET, ORALLY DISINTEGRATING003786044ANDA0915377073b706-1946-4ff2-8788-fb9452a59cae

risperidone 2 mg disintegrating oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580603NDAJanssen Pharmaceuticals, Inc.2003-04-02RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGNDA021444701e1cd8-2868-4d29-85a9-a2212c88165f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003786045ANDAMylan Pharmaceuticals Inc.2011-05-11RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA0915375958bb43-6967-4f15-9bd1-7f06340527ff
2007815312ANDASandoz Inc2009-12-22RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA078116e5ec2af6-7777-4dc2-9cea-eefc2629d5ad
3498840401ANDAPar Pharmaceutical Companies, Inc.2009-06-01RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA077494d0ef6df3-67e5-47b1-bcf7-f67aa030caca
4551110209ANDADr. Reddy'S Laboratories Ltd2009-02-24RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA077328c00809e1-e632-f246-97d9-73e1f9804587
5597460030ANDAJubilant Cadista Pharmaceuticals, Inc.2010-12-01RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA090839739dcf8a-ed73-5eb0-899b-7e51cb73c335
6627560702ANDASun Pharmaceutical Industries Limited2013-04-13RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA07846414603eab-6683-4c2a-b9fc-263142af5651
7633040951ANDARnabaxy Pharmaceuticals Inc.2010-08-06RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA077542f91f551e-926f-440d-83d2-357e9d7484fe

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1510790346ANDAMylan Institutional Inc.2011-06-10RISPERIDONEORALTABLET, ORALLY DISINTEGRATING003786045ANDA0915377073b706-1946-4ff2-8788-fb9452a59cae

risperidone 3 mg disintegrating oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580604NDAJanssen Pharmaceuticals, Inc.2003-04-02RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGNDA021444701e1cd8-2868-4d29-85a9-a2212c88165f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003786046ANDAMylan Pharmaceuticals Inc.2011-05-11RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA0915375958bb43-6967-4f15-9bd1-7f06340527ff
2007815313ANDASandoz Inc2009-12-22RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA078116e5ec2af6-7777-4dc2-9cea-eefc2629d5ad
3498840402ANDAPar Pharmaceutical Companies, Inc.2009-06-01RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA077494d0ef6df3-67e5-47b1-bcf7-f67aa030caca
4551110470ANDADr. Reddy'S Laboratories Ltd2009-11-30RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA077328c00809e1-e632-f246-97d9-73e1f9804587
5597460040ANDAJubilant Cadista Pharmaceuticals, Inc.2010-12-01RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA090839739dcf8a-ed73-5eb0-899b-7e51cb73c335
6627560633ANDASun Pharmaceutical Industries Limited2013-04-13RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA07846414603eab-6683-4c2a-b9fc-263142af5651
7633040643ANDARnabaxy Pharmaceuticals Inc.2010-08-06RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA078474f91f551e-926f-440d-83d2-357e9d7484fe

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1510790347ANDAMylan Institutional Inc.2011-06-10RISPERIDONEORALTABLET, ORALLY DISINTEGRATING003786046ANDA0915377073b706-1946-4ff2-8788-fb9452a59cae

risperidone 4 mg disintegrating oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580605NDAJanssen Pharmaceuticals, Inc.2003-04-02RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGNDA021444701e1cd8-2868-4d29-85a9-a2212c88165f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003786047ANDAMylan Pharmaceuticals Inc.2011-05-11RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA0915375958bb43-6967-4f15-9bd1-7f06340527ff
2007815314ANDASandoz Inc2009-12-22RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA078116e5ec2af6-7777-4dc2-9cea-eefc2629d5ad
3498840403ANDAPar Pharmaceutical Companies, Inc.2009-06-01RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA077494d0ef6df3-67e5-47b1-bcf7-f67aa030caca
4551110471ANDADr. Reddy'S Laboratories Ltd2009-11-30RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA077328c00809e1-e632-f246-97d9-73e1f9804587
5597460050ANDAJubilant Cadista Pharmaceuticals, Inc.2010-12-01RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA090839739dcf8a-ed73-5eb0-899b-7e51cb73c335
6627560634ANDASun Pharmaceutical Industries Limited2013-04-13RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA07846414603eab-6683-4c2a-b9fc-263142af5651
7633040644ANDARnabaxy Pharmaceuticals Inc.2010-08-06RISPERIDONEORALTABLET, ORALLY DISINTEGRATINGANDA078474f91f551e-926f-440d-83d2-357e9d7484fe

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA076908RISPERIDONETEVA PHARMACEUTICALS USA INC2012-03-12ANDA076908_001, ANDA076908_002, ANDA076908_003
2ANDA076996RISPERIDONEACTAVIS LABORATORIES FL INC2011-04-19ANDA076996_001, ANDA076996_002, ANDA076996_003, ANDA076996_004, ANDA076996_005
3ANDA077328RISPERIDONEDR REDDYS LABORATORIES LTD2009-02-24ANDA077328_001, ANDA077328_002, ANDA077328_003
4ANDA077494RISPERIDONEPAR PHARMACEUTICAL INC2009-04-30ANDA077494_001, ANDA077494_002, ANDA077494_003, ANDA077494_004, ANDA077494_005, ANDA077494_006
5ANDA077542RISPERIDONESUN PHARMACEUTICAL INDUSTRIES LTD2010-08-06ANDA077542_001, ANDA077542_002, ANDA077542_003
6ANDA078116RISPERIDONESANDOZ INC2009-12-22ANDA078116_001, ANDA078116_002, ANDA078116_003, ANDA078116_004, ANDA078116_005
7ANDA078464RISPERIDONESUN PHARMACEUTICAL INDUSTRIES LTD2013-04-08ANDA078464_001, ANDA078464_002, ANDA078464_003, ANDA078464_004, ANDA078464_005
8ANDA078474RISPERIDONESUN PHARMACEUTICAL INDUSTRIES LTD2010-08-06ANDA078474_001, ANDA078474_002
9ANDA078516RISPERIDONEZYDUS PHARMACEUTICALS USA INC2009-05-01ANDA078516_001, ANDA078516_003
10ANDA090839RISPERIDONEJUBILANT GENERICS LTD2011-11-04ANDA090839_001, ANDA090839_002, ANDA090839_003, ANDA090839_004, ANDA090839_005
11ANDA091537RISPERIDONEMYLAN PHARMACEUTICALS INC2011-03-30ANDA091537_001, ANDA091537_002, ANDA091537_003, ANDA091537_004, ANDA091537_005, ANDA091537_006
12NDA021444RISPERDALJANSSEN PHARMACEUTICALS INC2003-04-02p6224905, SUBSTANCE
p5648093, SUBSTANCE
NDA021444_001, NDA021444_002, NDA021444_003, NDA021444_004, NDA021444_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076908_001RXRISPERIDONE (0.5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2012-03-12RISPERIDONE
2ANDA076908_002RXRISPERIDONE (1MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2012-03-12RISPERIDONE
3ANDA076908_003RXRISPERIDONE (2MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2012-03-12RISPERIDONE
4ANDA076996_001RXRISPERIDONE (0.5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-04-19RISPERIDONE
5ANDA076996_002RXRISPERIDONE (1MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-04-19RISPERIDONE
6ANDA076996_003RXRISPERIDONE (2MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-04-19RISPERIDONE
7ANDA076996_004RXRISPERIDONE (3MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-04-19RISPERIDONE
8ANDA076996_005RXRISPERIDONE (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-04-19RISPERIDONE
9ANDA077328_001RXRISPERIDONE (0.5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-02-24RISPERIDONE
10ANDA077328_002RXRISPERIDONE (1MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-10-05RISPERIDONE
11ANDA077328_003RXRISPERIDONE (2MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-02-24RISPERIDONE
12ANDA077494_001RXRISPERIDONE (0.25MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-04-30RISPERIDONE
13ANDA077494_002RXRISPERIDONE (0.5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-04-30RISPERIDONE
14ANDA077494_003RXRISPERIDONE (1MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-10-26RISPERIDONE
15ANDA077494_004RXRISPERIDONE (2MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-04-30RISPERIDONE
16ANDA077494_005RXRISPERIDONE (3MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-04-30RISPERIDONE
17ANDA077494_006RXRISPERIDONE (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-04-30RISPERIDONE
18ANDA077542_001RXRISPERIDONE (0.5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2010-08-06RISPERIDONE
19ANDA077542_002RXRISPERIDONE (1MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2010-08-06RISPERIDONE
20ANDA077542_003RXRISPERIDONE (2MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2010-08-06RISPERIDONE
21ANDA078116_001RXRISPERIDONE (0.5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-12-22RISPERIDONE
22ANDA078116_002RXRISPERIDONE (1MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-12-22RISPERIDONE
23ANDA078116_003RXRISPERIDONE (2MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-12-22RISPERIDONE
24ANDA078116_004RXRISPERIDONE (3MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-12-22RISPERIDONE
25ANDA078116_005RXRISPERIDONE (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-12-22RISPERIDONE
26ANDA078464_001RXRISPERIDONE (0.5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-04-08RISPERIDONE
27ANDA078464_002RXRISPERIDONE (1MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-04-08RISPERIDONE
28ANDA078464_003RXRISPERIDONE (2MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-04-08RISPERIDONE
29ANDA078464_004RXRISPERIDONE (3MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-04-08RISPERIDONE
30ANDA078464_005RXRISPERIDONE (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-04-08RISPERIDONE
31ANDA078474_001RXRISPERIDONE (3MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2010-08-06RISPERIDONE
32ANDA078474_002RXRISPERIDONE (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2010-08-06RISPERIDONE
33ANDA078516_001RXRISPERIDONE (0.5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-05-01RISPERIDONE
34ANDA078516_003RXRISPERIDONE (2MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2009-05-01RISPERIDONE
35ANDA090839_001RXRISPERIDONE (0.5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-11-04RISPERIDONE
36ANDA090839_002RXRISPERIDONE (1MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-11-04RISPERIDONE
37ANDA090839_003RXRISPERIDONE (2MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-11-04RISPERIDONE
38ANDA090839_004RXRISPERIDONE (3MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-11-04RISPERIDONE
39ANDA090839_005RXRISPERIDONE (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-11-04RISPERIDONE
40ANDA091537_001RXRISPERIDONE (0.5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-03-30RISPERIDONE
41ANDA091537_002RXRISPERIDONE (1MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-03-30RISPERIDONE
42ANDA091537_003RXRISPERIDONE (2MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-03-30RISPERIDONE
43ANDA091537_004RXRISPERIDONE (3MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-03-30RISPERIDONE
44ANDA091537_005RXRISPERIDONE (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-03-30RISPERIDONE
45ANDA091537_006RXRISPERIDONE (0.25MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2013-02-12RISPERIDONE
46NDA021444_001RXRISPERIDONE (0.5MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2003-04-02RISPERDAL
47NDA021444_002RXRISPERIDONE (1MG)ORALTABLET, ORALLY DISINTEGRATINGTrueAB2003-04-02RISPERDAL
48NDA021444_003RXRISPERIDONE (2MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2003-04-02RISPERDAL
49NDA021444_004RXRISPERIDONE (3MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2004-12-23RISPERDAL
50NDA021444_005RXRISPERIDONE (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2004-12-23RISPERDAL

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5648093 (view patent)2014-07-15NDA021444, NDA020767, NDA021479Selegiline Disintegrating Oral Tablet
2p6224905 (view patent)2017-06-10NDA021444

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
114603eab-6683-4c2a-b9fc-263142af5651 (view SPL)These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone orally disintegrating tablets, USP.RISPERIDONE orally disintegrating tablets, USP, for oral useInitial U.S. Approval: 1993prescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2015-05-135627560633, 627560634, 627560700, 627560701, 627560702
21522f0b9-2bbc-4785-bada-fa6ae7986bb4 (view SPL)These highlights do not include all the information needed to use RISPERIDONE safely and effectively. See full prescribing information for RISPERIDONE.Initial U.S. Approval: 1993prescriptionHuman PrescriptionCadila Healthcare LimitedAnalysis, Manufacture2012-11-285658410640
32c62c65f-527e-44ed-8491-30db3eb8b902 (view SPL)These highlights do not include all the information needed to use RISPERIDONE safely and effectively. See full prescribing information for RISPERIDONE.Initial U.S. Approval: 1993prescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.Analysis, Manufacture2014-05-097683820154
45958bb43-6967-4f15-9bd1-7f06340527ff (view SPL)These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone orally disintegrating tablets. RISPERIDONE orally disintegrating tablets USP, for oral useInitial U.S. Approval: 1993prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-12-3012003786042, 003786043, 003786044, 003786045, 003786046, 003786047
5701e1cd8-2868-4d29-85a9-a2212c88165f (view SPL)These highlights do not include all the information needed to use Risperidone Tablets, Oral Solution, and Orally Disintegrating Tablets safely and effectively. See full prescribing information for Risperidone Tablets, Oral Solution, and Orally Disintegrating Tablets. Risperidone Tablets, Risperidone Oral Solution, Risperidone Orally Disintegrating Tablets Initial U.S. Approval: 1993prescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2014-05-1210504580601, 504580602, 504580603, 504580604, 504580605, 504580590, 504580591, 504580592, 504580593, 504580594, 504580595, 504580596Risperidone Oral Tablet
Risperidone Oral Solution
67073b706-1946-4ff2-8788-fb9452a59cae (view SPL)These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone orally disintegrating tablets. RISPERIDONE orally disintegrating tablets USP, for oral useInitial U.S. Approval: 1993prescriptionHuman PrescriptionMylan Institutional Inc.2015-07-033510790345, 510790346, 510790347
7739dcf8a-ed73-5eb0-899b-7e51cb73c335 (view SPL)These highlights do not include all the information needed to use Risperidone Orally Disintegrating Tablets USPsafely and effectively. See full prescribing information for Risperidone Orally Disintegrating Tablets USP. Risperidone Orally Disintegrating Tablets, USP Initial U.S. Approval: 1993prescriptionHuman PrescriptionJubilant Cadista Pharmaceuticals, Inc.2014-12-2311597460010, 597460020, 597460030, 597460040, 597460050
87e117c7e-02fc-4343-92a1-230061dfc5e0 (view SPL)These highlights do not include all the information needed to use RISPERDAL safely and effectively. See full prescribing information for RISPERDAL. RISPERDAL (risperidone) tablets, for oral use RISPERDAL (risperidone) oral solution RISPERDAL M-TAB (risperidone) orally disintegrating tablets Initial U.S. Approval: 1993prescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2014-05-0615504580300, 504580301, 504580302, 504580305, 504580315, 504580320, 504580325, 504580330, 504580335, 504580350, 504580355, 504580395Risperidone Oral Tablet
Risperidone Oral Solution
9c00809e1-e632-f246-97d9-73e1f9804587 (view SPL)These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone . Risperidone Orally Disintegrating Tablet s USP Initial U.S. Approval : 1993prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2013-10-2913551110207, 551110208, 551110209, 551110470, 551110471
10d0ef6df3-67e5-47b1-bcf7-f67aa030caca (view SPL)These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone.risperiDONE Orally Disintegrating Tablets, USPInitial U.S. Approval: 1993prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2015-02-1815498840212, 498840311, 498840315, 498840401, 498840402, 498840403
11e5ec2af6-7777-4dc2-9cea-eefc2629d5ad (view SPL)These highlights do not include all the information needed to use risperidone orally disintegrating tablets, USP safely and effectively. See full prescribing information for risperidone orally disintegrating tablets, USP. RISPERIDONE Orally Disintegrating Tablets, USP Initial U.S. Approval: 1993prescriptionHuman PrescriptionSandoz Inc2014-07-158007815310, 007815311, 007815312, 007815313, 007815314
12f91f551e-926f-440d-83d2-357e9d7484fe (view SPL)These highlights do not include all the information needed to use risperidone orally disintegrating tablets safely and effectively. See full prescribing information for risperidone orally disintegrating tablets. Risperidone orally disintegrating tablets, for oral use Initial U.S. Approval: 1993prescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.FDF MANUFACTURE, api manufacture2014-05-305633040643, 633040644, 633040949, 633040950, 633040951

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII