Sulindac Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Epic Pharma, Llc (2015-08-03)
Oldest Current Product
1990-04-03
License(s)
ANDA
RxNORM
ORAL TABLET\SULINDAC
FDAOB
ORAL\TABLET\SULINDAC
SPL Active
ORAL\TABLET\SULINDAC
SPL Moiety
ORAL\TABLET\SULINDAC

product(s) by strength(s)

sulindac 150 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780427ANDAMylan Pharmaceuticals Inc.1993-06-22SULINDACORALTABLETANDA073039473edb3e-ccaa-4a74-8dc8-6a053c52d3e0
2005915661ANDAWatson Laboratories, Inc.1990-04-03SULINDACORALTABLETANDA071891d8b9d517-5dd4-4c6b-8aa0-736bce87e7b4
3009046216ANDAMajor2010-11-30SULINDACORALTABLETANDA0727111a5125c7-a63e-4214-b179-668ecfcd16ac
4231550005ANDAHeritage Pharmaceuticals Inc.2007-07-16SULINDACORALTABLETANDA073262a9530bbf-839e-4be5-9653-468f058f5302
5428060018ANDAEpic Pharma, Llc2010-01-25SULINDACORALTABLETANDA07271096c73bd2-4577-487d-a642-bd8f91e94c3a
6428060624ANDAEpic Pharma, Llc2015-07-28SULINDACORALTABLETANDA07326214f7c1e4-e905-409b-9445-c036950ca36a
7534890478ANDAMutual Pharmaceutical Company, Inc.2009-09-04SULINDACORALTABLETANDA072050a47e4259-d44b-4b7b-b517-841cb6840982
8547380902ANDARichmond Pharmaceuticals2009-09-04SULINDACORALTABLETANDA07205089b01ca5-cfa5-4f5d-be6b-927d58cce0f2

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1538080799ANDAState Of Florida Doh Central Pharmacy2009-07-01SULINDACORALTABLET231550005ANDA073262d126f8a4-bc39-453c-bdd4-764ce4e1760d
2548680879ANDAPhysicians Total Care, Inc.2007-07-04SULINDACORALTABLET005915661ANDA071891b906d325-27f1-4fb4-86ab-a2c896470e1e
3604290171ANDAGolden State Medical Supply, Inc.2010-01-25SULINDACORALTABLET428060018ANDA07271019dde540-3d29-4db4-9570-6ca15f09e0fe
4636294965ANDABryant Ranch Prepack1990-04-03SULINDACORALTABLET005915661ANDA071891d2963a85-4841-4d19-9892-670a737852b0

sulindac 200 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780531ANDAMylan Pharmaceuticals Inc.1993-06-22SULINDACORALTABLETANDA073039473edb3e-ccaa-4a74-8dc8-6a053c52d3e0
2005915660ANDAWatson Laboratories, Inc.1990-04-03SULINDACORALTABLETANDA071795d8b9d517-5dd4-4c6b-8aa0-736bce87e7b4
3009046217ANDAMajor2010-11-30SULINDACORALTABLETANDA0727111a5125c7-a63e-4214-b179-668ecfcd16ac
4231550006ANDAHeritage Pharmaceuticals Inc.2007-07-16SULINDACORALTABLETANDA073262a9530bbf-839e-4be5-9653-468f058f5302
5428060011ANDAEpic Pharma, Llc2010-01-25SULINDACORALTABLETANDA07271196c73bd2-4577-487d-a642-bd8f91e94c3a
6428060625ANDAEpic Pharma, Llc2015-07-28SULINDACORALTABLETANDA07326214f7c1e4-e905-409b-9445-c036950ca36a
7534890479ANDAMutual Pharmaceutical Company, Inc.2009-09-04SULINDACORALTABLETANDA072051a47e4259-d44b-4b7b-b517-841cb6840982
8547380903ANDARichmond Pharmaceuticals2009-09-04SULINDACORALTABLETANDA07205189b01ca5-cfa5-4f5d-be6b-927d58cce0f2

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009043379ANDAMajor2009-09-04SULINDACORALTABLET534890479ANDA0720517df95320-2670-48c9-b75d-8e341cc0e08b
2165900211ANDAStat Rx Usa Llc2010-01-25SULINDACORALTABLET428060011ANDA072711c17e8534-4e71-4166-a4fc-9df6cf6dd49b
3332610100ANDAAidarex Pharmaceuticals Llc2010-01-25SULINDACORALTABLET428060011ANDA0727117a0afa8a-9660-453b-a47d-29c20a8d2d6b
4499990656ANDALake Erie Medical Dba Quality Care Products Llc2010-06-23SULINDACORALTABLET005915660ANDA0717956f50bddb-e90d-4a2b-8716-9c1b84f5a22f
5510790667ANDAMylan Institutional Inc.1997-01-31SULINDACORALTABLET003780531ANDA0730397b16d772-ef1f-4f41-a0d4-47e3e38024e1
6529590195ANDAH.J. Harkins Company, Inc.1990-04-03SULINDACORALTABLET005915660ANDA071795145a1b4a-16ef-4f29-b47e-f52c47514c9a
7538080302ANDAState Of Florida Doh Central Pharmacy2009-07-01SULINDACORALTABLET534890479ANDA07205187449866-cf27-4c2f-b57b-a967408e0d63
8538080303ANDAState Of Florida Doh Central Pharmacy2009-07-01SULINDACORALTABLET231550006ANDA073262b5b9be81-f0b8-4ee2-bcfd-38fbe3805c06
9538080814ANDAState Of Florida Doh Central Pharmacy2013-01-01SULINDACORALTABLET428060011ANDA072711df5f89a8-70b3-40bc-8a05-8daa8c881d06
10548681118ANDAPhysicians Total Care, Inc.2007-07-05SULINDACORALTABLET005915660ANDA071795b906d325-27f1-4fb4-86ab-a2c896470e1e
11552890930ANDAPd-Rx Pharmaceuticals, Inc.1990-04-03SULINDACORALTABLET005915660ANDA07179568d4eeed-2501-494b-b979-502720de86c0
12604290172ANDAGolden State Medical Supply, Inc.2010-01-25SULINDACORALTABLET428060011ANDA07271119dde540-3d29-4db4-9570-6ca15f09e0fe
13636293208ANDABryant Ranch Prepack1990-04-03SULINDACORALTABLET005915660ANDA071795d150c3f3-c267-4d48-9502-4700670c954b
14681512871ANDACarilion Materials Management1990-04-03SULINDACORALTABLET005915660ANDA071795b8b549e9-53ec-407a-a505-b652faf8f3b6
15681512872ANDACarilion Materials Management1990-04-03SULINDACORALTABLET005915660ANDA071795a399a9e2-5413-434c-ae1a-26ac7b796082

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA071795SULINDACWATSON LABORATORIES INC1990-04-03ANDA071795_001
2ANDA071891SULINDACWATSON LABORATORIES INC1990-04-03ANDA071891_001
3ANDA072050SULINDACMUTUAL PHARMACEUTICAL CO INC1991-04-17ANDA072050_001
4ANDA072051SULINDACMUTUAL PHARMACEUTICAL CO INC1991-04-17ANDA072051_001
5ANDA072710SULINDACEPIC PHARMA LLC1991-03-25ANDA072710_001
6ANDA072711SULINDACEPIC PHARMA LLC1991-03-25ANDA072711_001
7ANDA072712SULINDACTrueSANDOZ INC1991-08-30ANDA072712_001
8ANDA072713SULINDACTrueSANDOZ INC1991-08-30ANDA072713_001
9ANDA072972SULINDACTrueANI PHARMACEUTICALS INC1992-02-28ANDA072972_001
10ANDA072973SULINDACTrueANI PHARMACEUTICALS INC1992-02-28ANDA072973_001
11ANDA073039SULINDACMYLAN PHARMACEUTICALS INC1993-06-22ANDA073039_001, ANDA073039_002
12ANDA073262SULINDACHERITAGE PHARMACEUTICALS INC1991-09-06ANDA073262_001, ANDA073262_002
13NDA017911CLINORILMERCK RESEARCH LABORATORIES DIV MERCK CO INCNDA017911_001, NDA017911_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA071795_001RXSULINDAC (200MG)ORALTABLETFalseAB1990-04-03SULINDAC
2ANDA071891_001RXSULINDAC (150MG)ORALTABLETFalseAB1990-04-03SULINDAC
3ANDA072050_001RXSULINDAC (150MG)ORALTABLETFalseAB1991-04-17SULINDAC
4ANDA072051_001RXSULINDAC (200MG)ORALTABLETFalseAB1991-04-17SULINDAC
5ANDA072710_001RXSULINDAC (150MG)ORALTABLETFalseAB1991-03-25SULINDAC
6ANDA072711_001RXSULINDAC (200MG)ORALTABLETFalseAB1991-03-25SULINDAC
7ANDA072712_001discontinuedSULINDAC (150MG)ORALTABLETFalse1991-08-30SULINDAC
8ANDA072713_001discontinuedSULINDAC (200MG)ORALTABLETFalse1991-08-30SULINDAC
9ANDA072972_001discontinuedSULINDAC (150MG)ORALTABLETFalse1992-02-28SULINDAC
10ANDA072973_001discontinuedSULINDAC (200MG)ORALTABLETFalse1992-02-28SULINDAC
11ANDA073039_001RXSULINDAC (200MG)ORALTABLETFalseAB1993-06-22SULINDAC
12ANDA073039_002RXSULINDAC (150MG)ORALTABLETFalseAB1993-06-22SULINDAC
13ANDA073262_001RXSULINDAC (200MG)ORALTABLETFalseAB1991-09-06SULINDAC
14ANDA073262_002RXSULINDAC (150MG)ORALTABLETFalseAB1991-09-06SULINDAC
15NDA017911_001discontinuedSULINDAC (150MG)ORALTABLETFalseCLINORIL
16NDA017911_002RXSULINDAC (200MG)ORALTABLETTrueABCLINORIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1145a1b4a-16ef-4f29-b47e-f52c47514c9a (view SPL)Sulindac Tablets USP Revised: June 2009 Rx only 190770prescriptionHuman PrescriptionH.J. Harkins Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-10-281529590195
214f7c1e4-e905-409b-9445-c036950ca36a (view SPL)Sulindac Tablets USP, 150 mg and 200 mg Rx onlyprescriptionHuman PrescriptionEpic Pharma, LlcMANUFACTURE2015-07-281428060624, 428060625
319dde540-3d29-4db4-9570-6ca15f09e0fe (view SPL)Sulindac Tablets USP, 150 mg and 200 mgRx onlyprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-011604290171, 604290172
41a5125c7-a63e-4214-b179-668ecfcd16ac (view SPL)Sulindac Tablets USP, 150 mg and 200 mgRx onlyprescriptionHuman PrescriptionMajorMANUFACTURE2015-07-284009046216, 009046217
5473edb3e-ccaa-4a74-8dc8-6a053c52d3e0 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-07-215003780427, 003780531
668d4eeed-2501-494b-b979-502720de86c0 (view SPL)Sulindac Tablets USP Revised: June 2009 Rx only 190770prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-07-121552890930
76f50bddb-e90d-4a2b-8716-9c1b84f5a22f (view SPL)Sulindac 200 mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2010-06-23325499990656
87a0afa8a-9660-453b-a47d-29c20a8d2d6b (view SPL)Sulindac Tablets USP, 150 mg and 200 mgRx onlyprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-02-031332610100
97b16d772-ef1f-4f41-a0d4-47e3e38024e1 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2013-10-042510790667
107df95320-2670-48c9-b75d-8e341cc0e08b (view SPL)SULINDAC TABLETS USPprescriptionHuman PrescriptionMajorRELABEL, REPACK2011-04-074009043379
1187449866-cf27-4c2f-b57b-a967408e0d63 (view SPL)SULINDAC TABLETS USPprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-05-211538080302
1289b01ca5-cfa5-4f5d-be6b-927d58cce0f2 (view SPL)SULINDAC TABLETS USPprescriptionHuman PrescriptionRichmond Pharmaceuticals2011-04-192547380902, 547380903
1396c73bd2-4577-487d-a642-bd8f91e94c3a (view SPL)Sulindac Tablets USP, 150 mg and 200 mg Rx onlyprescriptionHuman PrescriptionEpic Pharma, LlcMANUFACTURE2015-08-039428060011, 428060018
14a399a9e2-5413-434c-ae1a-26ac7b796082 (view SPL)Sulindac Tablets USP Revised: June 2009 Rx only 190770prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2010-07-122681512872
15a47e4259-d44b-4b7b-b517-841cb6840982 (view SPL)SULINDAC TABLETS USPprescriptionHuman PrescriptionMutual Pharmaceutical Company, Inc.2014-12-2310534890478, 534890479
16a9530bbf-839e-4be5-9653-468f058f5302 (view SPL)SULINDAC TABLETS, USPprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE2012-08-106231550005, 231550006
17b5b9be81-f0b8-4ee2-bcfd-38fbe3805c06 (view SPL)SULINDAC TABLETS, USPprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-05-211538080303
18b8b549e9-53ec-407a-a505-b652faf8f3b6 (view SPL)Sulindac Tablets USP Revised: June 2009 Rx only 190770prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2010-07-122681512871
19b906d325-27f1-4fb4-86ab-a2c896470e1e (view SPL)Sulindac Tablets USP Revised: June 2009 Rx only 190770prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-07-122548680879, 548681118
20c17e8534-4e71-4166-a4fc-9df6cf6dd49b (view SPL)Sulindac Tablets USP 200 mg Rx onlyprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-08-171165900211
21d126f8a4-bc39-453c-bdd4-764ce4e1760d (view SPL)SULINDAC TABLETS, USPprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-04-131538080799
22d150c3f3-c267-4d48-9502-4700670c954b (view SPL)Sulindac Tablets USP Revised: June 2009 Rx only 190770prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-281001636293208
23d2963a85-4841-4d19-9892-670a737852b0 (view SPL)Sulindac Tablets USP Revised: June 2009 Rx only 190770prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-081000636294965
24d8b9d517-5dd4-4c6b-8aa0-736bce87e7b4 (view SPL)Sulindac Tablets USP Revised: June 2009 Rx only 190770prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2010-07-121005915660, 005915661
25df5f89a8-70b3-40bc-8a05-8daa8c881d06 (view SPL)Sulindac Tablets USP, 150 mg and 200 mgRx onlyprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2013-09-301538080814

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