Nisoldipine Extended Release Oral Tablet

Brand(s)
Sular
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Shionogi Inc. (2015-03-19)
Oldest Current Product
1995-02-02
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\NISOLDIPINE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\NISOLDIPINE
SPL Active
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\NISOLDIPINE
SPL Moiety
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\NISOLDIPINE

product(s) by strength(s)

24 hr nisoldipine 17 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596300501SularNDAShionogi Inc.1995-02-02NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASENDA020356bcdeafac-f4ef-4dda-bdb7-1f819c33bb76

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003782097ANDAMylan Pharmaceuticals Inc.2011-01-28NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASEANDA09100100d506a4-74d6-4838-b008-3f9e7c017e08
2006771979NDA AUTHORIZED GENERICUnited Research Laboratories, Inc.2009-09-01NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASENDA0203562abc5435-b2ca-4e08-89bc-ab7526781819
3669930473NDA AUTHORIZED GENERICPrasco Laboratories2012-02-27NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASENDA0203568a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb

24 hr nisoldipine 20 mg extended release oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003782222ANDAMylan Pharmaceuticals Inc.2008-07-25NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASEANDA079051a6a8a8ba-3966-4f37-a58b-44d3b05bdc4e

24 hr nisoldipine 25.5 mg extended release oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003782098ANDAMylan Pharmaceuticals Inc.2011-01-28NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASEANDA09100100d506a4-74d6-4838-b008-3f9e7c017e08
2006771980NDA AUTHORIZED GENERICUnited Research Laboratories, Inc.2009-09-01NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASENDA0203562abc5435-b2ca-4e08-89bc-ab7526781819

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685993SularNDAPhysicians Total Care, Inc.2009-02-24NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASE596300502NDA020356e3780ba1-46ef-410c-b2fc-f1ffbfb598f3

24 hr nisoldipine 30 mg extended release oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003782223ANDAMylan Pharmaceuticals Inc.2008-07-25NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASEANDA079051a6a8a8ba-3966-4f37-a58b-44d3b05bdc4e

24 hr nisoldipine 34 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596300503SularNDAShionogi Inc.1995-02-02NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASENDA020356bcdeafac-f4ef-4dda-bdb7-1f819c33bb76

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003782099ANDAMylan Pharmaceuticals Inc.2011-01-28NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASEANDA09100100d506a4-74d6-4838-b008-3f9e7c017e08
2006771981NDA AUTHORIZED GENERICUnited Research Laboratories, Inc.2009-09-01NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASENDA0203562abc5435-b2ca-4e08-89bc-ab7526781819
3669930475NDA AUTHORIZED GENERICPrasco Laboratories2012-02-27NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASENDA0203568a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb

24 hr nisoldipine 40 mg extended release oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003782224ANDAMylan Pharmaceuticals Inc.2008-07-25NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASEANDA079051a6a8a8ba-3966-4f37-a58b-44d3b05bdc4e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685931ANDAPhysicians Total Care, Inc.2008-08-29NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASE003782224ANDA079051bab6e4c1-6ebd-4dbd-af90-12486f4f4ea6

24 hr nisoldipine 8.5 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596300500SularNDAShionogi Inc.1995-02-02NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASENDA020356bcdeafac-f4ef-4dda-bdb7-1f819c33bb76

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003782096ANDAMylan Pharmaceuticals Inc.2011-01-28NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASEANDA09100100d506a4-74d6-4838-b008-3f9e7c017e08
2006771978NDA AUTHORIZED GENERICUnited Research Laboratories, Inc.2009-09-01NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASENDA0203562abc5435-b2ca-4e08-89bc-ab7526781819
3669930472NDA AUTHORIZED GENERICPrasco Laboratories2012-02-27NISOLDIPINEORALTABLET, FILM COATED, EXTENDED RELEASENDA0203568a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA079051NISOLDIPINEMYLAN PHARMACEUTICALS INC2008-07-25ANDA079051_001, ANDA079051_002, ANDA079051_003
2ANDA091001NISOLDIPINEMYLAN PHARMACEUTICALS INC2011-01-26ANDA091001_001, ANDA091001_002, ANDA091001_003, ANDA091001_004
3NDA020356SULARSHIONOGI INC1995-02-02p5626874, SUBSTANCENDA020356_001, NDA020356_002, NDA020356_003, NDA020356_004, NDA020356_005, NDA020356_006, NDA020356_007, NDA020356_008

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA079051_001RXNISOLDIPINE (20MG)ORALTABLET, EXTENDED RELEASEFalse2008-07-25NISOLDIPINE
2ANDA079051_002RXNISOLDIPINE (30MG)ORALTABLET, EXTENDED RELEASETrue2008-07-25NISOLDIPINE
3ANDA079051_003RXNISOLDIPINE (40MG)ORALTABLET, EXTENDED RELEASETrue2008-07-25NISOLDIPINE
4ANDA091001_001RXNISOLDIPINE (8.5MG)ORALTABLET, EXTENDED RELEASEFalseAB2011-01-26NISOLDIPINE
5ANDA091001_002RXNISOLDIPINE (17MG)ORALTABLET, EXTENDED RELEASEFalseAB2011-01-26NISOLDIPINE
6ANDA091001_003RXNISOLDIPINE (25.5MG)ORALTABLET, EXTENDED RELEASEFalse2011-01-26NISOLDIPINE
7ANDA091001_004RXNISOLDIPINE (34MG)ORALTABLET, EXTENDED RELEASEFalseAB2011-01-26NISOLDIPINE
8NDA020356_001discontinuedNISOLDIPINE (10MG)ORALTABLET, EXTENDED RELEASEFalse1995-02-02SULAR
9NDA020356_002discontinuedNISOLDIPINE (20MG)ORALTABLET, EXTENDED RELEASEFalse1995-02-02SULAR
10NDA020356_003discontinuedNISOLDIPINE (30MG)ORALTABLET, EXTENDED RELEASEFalse1995-02-02SULAR
11NDA020356_004discontinuedNISOLDIPINE (40MG)ORALTABLET, EXTENDED RELEASEFalse1995-02-02SULAR
12NDA020356_005RXNISOLDIPINE (34MG)ORALTABLET, EXTENDED RELEASETrueAB2008-01-02SULAR
13NDA020356_006discontinuedNISOLDIPINE (25.5MG)ORALTABLET, EXTENDED RELEASEFalse2008-01-02SULAR
14NDA020356_007RXNISOLDIPINE (17MG)ORALTABLET, EXTENDED RELEASETrueAB2008-01-02SULAR
15NDA020356_008RXNISOLDIPINE (8.5MG)ORALTABLET, EXTENDED RELEASETrueAB2008-01-02SULAR

patent(s)

#idexpiration dateapplication(s)
1p5626874 (view patent)2014-11-30NDA020356

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
100d506a4-74d6-4838-b008-3f9e7c017e08 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2010-01-216003782096, 003782097, 003782098, 003782099
22abc5435-b2ca-4e08-89bc-ab7526781819 (view SPL)NisoldipineprescriptionHuman PrescriptionUnited Research Laboratories, Inc.2009-09-012006771978, 006771979, 006771980, 006771981
38a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb (view SPL)NisoldipineprescriptionHuman PrescriptionPrasco Laboratories2013-10-048669930472, 669930473, 669930475
4a6a8a8ba-3966-4f37-a58b-44d3b05bdc4e (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2008-06-105003782222, 003782223, 003782224
5bab6e4c1-6ebd-4dbd-af90-12486f4f4ea6 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-05-221548685931
6bcdeafac-f4ef-4dda-bdb7-1f819c33bb76 (view SPL)SULAR (nisoldipine)Extended Release TabletsFor Oral UseprescriptionHuman PrescriptionShionogi Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2015-03-199596300500, 596300501, 596300503
7e3780ba1-46ef-410c-b2fc-f1ffbfb598f3 (view SPL)Sular (nisoldipine)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-06-081548685993

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