nateglinide Oral Tablet

Brand(s)
Starlix
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2013-01-31)
Oldest Current Product
2000-12-04
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\NATEGLINIDE
FDAOB
ORAL\TABLET\NATEGLINIDE
SPL Active
ORAL\TABLET, COATED\NATEGLINIDE
ORAL\TABLET\NATEGLINIDE
SPL Moiety
ORAL\TABLET, COATED\NATEGLINIDE
ORAL\TABLET\NATEGLINIDE

product(s) by strength(s)

nateglinide 120 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780352StarlixNDANovartis Pharmaceuticals Corporation2000-12-04NATEGLINIDEORALTABLETNDA0212045cbda9bc-3c0d-4d75-a37a-994844680c8c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005913355ANDAWatson Laboratories, Inc.2011-03-30NATEGLINIDEORALTABLETANDA077462a7e9f62e-32f8-4a89-8588-74d029c8f6a2
2498840985ANDAPar Pharmaceutical Companies, Inc.2009-09-08NATEGLINIDEORALTABLET, COATEDANDA077463c8ab95a2-82e6-473a-aff3-291306997db6
3551110329ANDADr. Reddy'S Laboratories Ltd2009-09-09NATEGLINIDEORALTABLETANDA077461f7b28951-76d2-cabd-64a1-b74aa225c6e9

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157586ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2009-09-08NATEGLINIDEORALTABLET, COATED498840985ANDA077463f7e91323-1e7c-4c12-99aa-0959a9f6496c
2548686255ANDAPhysicians Total Care, Inc.2011-05-03NATEGLINIDEORALTABLET, COATED498840985ANDA077463b1cc7bfa-532b-45b0-92bf-18a83271166b
3680840459ANDAAmerican Health Packaging2012-01-02NATEGLINIDEORALTABLET, COATED498840985ANDA07746378679aac-28ba-4828-8189-4a2fc8de2b71

nateglinide 60 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780351StarlixNDANovartis Pharmaceuticals Corporation2000-12-04NATEGLINIDEORALTABLETNDA0212045cbda9bc-3c0d-4d75-a37a-994844680c8c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005913354ANDAWatson Laboratories, Inc.2011-03-30NATEGLINIDEORALTABLETANDA077462a7e9f62e-32f8-4a89-8588-74d029c8f6a2
2498840984ANDAPar Pharmaceutical Companies, Inc.2009-09-08NATEGLINIDEORALTABLET, COATEDANDA077463c8ab95a2-82e6-473a-aff3-291306997db6
3551110328ANDADr. Reddy'S Laboratories Ltd2009-09-09NATEGLINIDEORALTABLETANDA077461f7b28951-76d2-cabd-64a1-b74aa225c6e9

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157585ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2009-09-08NATEGLINIDEORALTABLET, COATED498840984ANDA077463f7e91323-1e7c-4c12-99aa-0959a9f6496c
2680840458ANDAAmerican Health Packaging2012-01-02NATEGLINIDEORALTABLET, COATED498840984ANDA07746378679aac-28ba-4828-8189-4a2fc8de2b71

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA077461NATEGLINIDEDR REDDYS LABORATORIES LTD2009-09-09ANDA077461_001, ANDA077461_002
2ANDA077462NATEGLINIDEWATSON LABORATORIES INC2011-03-30ANDA077462_001, ANDA077462_002
3ANDA077463NATEGLINIDEPAR PHARMACEUTICAL INC2009-09-09ANDA077463_001, ANDA077463_002
4ANDA077467NATEGLINIDETrueTEVA PHARMACEUTICALS USA2009-09-09ANDA077467_001, ANDA077467_002
5NDA021204STARLIXNOVARTIS PHARMACEUTICALS CORP2000-12-22p6844008, USE AS A BLOOD GLUCOSE-LOWERING AGENT, SUBSTANCE
p6641841, USE AS A BLOOD GLUCOSE-LOWERING AGENT, SUBSTANCE
p6559188, USE FOR TREATMENT OF DIABETES, SUBSTANCE
p6878749, SUBSTANCE
NDA021204_001, NDA021204_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077461_001RXNATEGLINIDE (60MG)ORALTABLETFalseAB2009-09-09NATEGLINIDE
2ANDA077461_002RXNATEGLINIDE (120MG)ORALTABLETFalseAB2009-09-09NATEGLINIDE
3ANDA077462_001RXNATEGLINIDE (60MG)ORALTABLETFalseAB2011-03-30NATEGLINIDE
4ANDA077462_002RXNATEGLINIDE (120MG)ORALTABLETFalseAB2011-03-30NATEGLINIDE
5ANDA077463_001RXNATEGLINIDE (60MG)ORALTABLETFalseAB2009-09-09NATEGLINIDE
6ANDA077463_002RXNATEGLINIDE (120MG)ORALTABLETFalseAB2009-09-09NATEGLINIDE
7ANDA077467_001discontinuedNATEGLINIDE (60MG)ORALTABLETFalse2009-09-09NATEGLINIDE
8ANDA077467_002discontinuedNATEGLINIDE (120MG)ORALTABLETFalse2009-09-09NATEGLINIDE
9NDA021204_001RXNATEGLINIDE (60MG)ORALTABLETFalseAB2000-12-22STARLIX
10NDA021204_002RXNATEGLINIDE (120MG)ORALTABLETTrueAB2000-12-22STARLIX

patent(s)

#idexpiration dateapplication(s)
1p6559188 (view patent)2020-09-15NDA021204
2p6641841 (view patent)2017-11-14NDA021204
3p6844008 (view patent)2017-11-14NDA021204
4p6878749 (view patent)2020-09-15NDA021204

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15cbda9bc-3c0d-4d75-a37a-994844680c8c (view SPL)StarlixprescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2013-01-316000780351, 000780352
278679aac-28ba-4828-8189-4a2fc8de2b71 (view SPL)NATEGLINIDEprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-01-173680840458, 680840459
3a7e9f62e-32f8-4a89-8588-74d029c8f6a2 (view SPL)Nateglinide tablets USPRx onlyPrescribing InformationprescriptionHuman PrescriptionWatson Laboratories, Inc.LABEL, MANUFACTURE, PACK2011-10-047005913354, 005913355
4b1cc7bfa-532b-45b0-92bf-18a83271166b (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-12-122548686255
5c8ab95a2-82e6-473a-aff3-291306997db6 (view SPL)prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.manufacture2011-11-284498840984, 498840985
6f7b28951-76d2-cabd-64a1-b74aa225c6e9 (view SPL)Nateglinide Tablets USPprescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2015-04-205551110328, 551110329
7f7e91323-1e7c-4c12-99aa-0959a9f6496c (view SPL)Nateglinide TabsprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2012-08-157006157585, 006157586

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