Nadolol Oral Tablet

Brand(s)
Corgard
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Greenstone Llc (2014-04-17)
Oldest Current Product
1979-12-10
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\NADOLOL
FDAOB
ORAL\TABLET\NADOLOL
SPL Active
ORAL\TABLET\NADOLOL
SPL Moiety
ORAL\TABLET\NADOLOL

product(s) by strength(s)

nadolol 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1607930800CorgardNDAPfizer Laboratories Div Pfizer Inc1979-12-10NADOLOLORALTABLETNDA018063c2e709d2-96a2-41ea-b5e9-9ce4ccb91f59

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934235ANDATeva Pharmaceuticals Usa Inc2008-11-03NADOLOLORALTABLETANDA0742290031ce9c-cb49-433a-aa74-8d20ca0563c0
2003780028ANDAMylan Pharmaceuticals Inc.1993-10-31NADOLOLORALTABLETANDA074172f1549a3d-a51a-40fa-bc97-ad5578e6f014
3007811181ANDASandoz Inc2008-10-01NADOLOLORALTABLETANDA074501c51d1463-64aa-486e-bc50-b92758be97b1
4597620810NDA AUTHORIZED GENERICGreenstone Llc2014-04-28NADOLOLORALTABLETNDA0180630d59bbfc-52a0-4631-9be4-d361a6e61d40
5680010221ANDABluepoint Laboratories2014-02-05NADOLOLORALTABLETANDA0745010152dffb-6575-4d15-9d67-019efa6ae5f6

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950802ANDARebel Distributors Corp2008-10-01NADOLOLORALTABLET007811181ANDA074501a4fc8ec9-99c6-4739-9f71-0d9062f3ebe9
2422540094ANDARebel Distributors Corp2011-01-18NADOLOLORALTABLET000934235ANDA0742290c6eed96-edfd-4e65-8eff-59d1ad51a59a
3510790812ANDAMylan Institutional Inc.1994-07-12NADOLOLORALTABLET003780028ANDA07417286b00a8e-f68b-4bf4-a555-d84637472cc2
4521250081ANDARemedyrepack Inc.2013-02-22NADOLOLORALTABLET000934236ANDA074229fc641590-db5e-4b4e-a8b1-fc812ba42825
5548685295ANDAPhysicians Total Care, Inc.2005-05-16NADOLOLORALTABLET003780028ANDA074172d208918b-a356-4924-91d9-9593981fe0a6
6680840696ANDAAmerican Health Packaging2014-04-01NADOLOLORALTABLET007811181ANDA074501f3614316-c120-4d49-9306-22b42dfbc4fd
7680840755ANDAAmerican Health Packaging2014-04-14NADOLOLORALTABLET680010221ANDA074501cbc3e50e-2329-4ec5-a809-439d3d77f27c

nadolol 40 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1607930801CorgardNDAPfizer Laboratories Div Pfizer Inc1979-12-10NADOLOLORALTABLETNDA018063c2e709d2-96a2-41ea-b5e9-9ce4ccb91f59

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934236ANDATeva Pharmaceuticals Usa Inc2008-11-03NADOLOLORALTABLETANDA0742290031ce9c-cb49-433a-aa74-8d20ca0563c0
2003781171ANDAMylan Pharmaceuticals Inc.1993-10-31NADOLOLORALTABLETANDA074172f1549a3d-a51a-40fa-bc97-ad5578e6f014
3007811182ANDASandoz Inc2008-10-01NADOLOLORALTABLETANDA074501c51d1463-64aa-486e-bc50-b92758be97b1
4597620811NDA AUTHORIZED GENERICGreenstone Llc2014-04-28NADOLOLORALTABLETNDA0180630d59bbfc-52a0-4631-9be4-d361a6e61d40
5680010220ANDABluepoint Laboratories2014-02-05NADOLOLORALTABLETANDA0745010152dffb-6575-4d15-9d67-019efa6ae5f6

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950799ANDARebel Distributors Corp2008-10-01NADOLOLORALTABLET007811182ANDA074501a4fc8ec9-99c6-4739-9f71-0d9062f3ebe9
2422540218ANDARebel Distributors Corp2011-01-18NADOLOLORALTABLET000934236ANDA074229ac3aa150-2083-4fb0-9663-e92c1dc3135a
3510790813ANDAMylan Institutional Inc.1994-07-12NADOLOLORALTABLET003781171ANDA07417286b00a8e-f68b-4bf4-a555-d84637472cc2
4548683257ANDAPhysicians Total Care, Inc.2010-01-14NADOLOLORALTABLET003781171ANDA074172d208918b-a356-4924-91d9-9593981fe0a6
5680840707ANDAAmerican Health Packaging2014-04-01NADOLOLORALTABLET007811182ANDA074501f3614316-c120-4d49-9306-22b42dfbc4fd
6680840763ANDAAmerican Health Packaging2014-04-14NADOLOLORALTABLET680010220ANDA074501cbc3e50e-2329-4ec5-a809-439d3d77f27c
7682586034ANDADispensing Solutions, Inc.2008-10-01NADOLOLORALTABLET007811182ANDA074501d04b1887-933e-4c85-9744-659fe1e56c61

nadolol 80 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1607930802CorgardNDAPfizer Laboratories Div Pfizer Inc1979-12-10NADOLOLORALTABLETNDA018063c2e709d2-96a2-41ea-b5e9-9ce4ccb91f59

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934237ANDATeva Pharmaceuticals Usa Inc2008-11-03NADOLOLORALTABLETANDA0742550031ce9c-cb49-433a-aa74-8d20ca0563c0
2003781132ANDAMylan Pharmaceuticals Inc.1993-10-31NADOLOLORALTABLETANDA074172f1549a3d-a51a-40fa-bc97-ad5578e6f014
3007811183ANDASandoz Inc2008-10-01NADOLOLORALTABLETANDA074501c51d1463-64aa-486e-bc50-b92758be97b1
4597620812NDA AUTHORIZED GENERICGreenstone Llc2014-04-28NADOLOLORALTABLETNDA0180630d59bbfc-52a0-4631-9be4-d361a6e61d40
5680010219ANDABluepoint Laboratories2014-02-05NADOLOLORALTABLETANDA0745010152dffb-6575-4d15-9d67-019efa6ae5f6

relabeler product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950800ANDARebel Distributors Corp2008-10-01NADOLOLORALTABLET007811183ANDA074501a4fc8ec9-99c6-4739-9f71-0d9062f3ebe9
2548683721ANDAPhysicians Total Care, Inc.2004-08-132010-06-30NADOLOLORALTABLET003781132ANDA074172d208918b-a356-4924-91d9-9593981fe0a6
3680840897ANDAAmerican Health Packaging2015-10-01NADOLOLORALTABLET680010219ANDA07450137781219-21d0-4bc5-91c4-92aafc8ab942

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074172NADOLOLMYLAN PHARMACEUTICALS INC1993-10-31ANDA074172_001, ANDA074172_002, ANDA074172_003
2ANDA074229NADOLOLIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1996-08-30ANDA074229_001, ANDA074229_002
3ANDA074255NADOLOLIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1996-01-24ANDA074255_001, ANDA074255_002, ANDA074255_003
4ANDA074368NADOLOLTrueTEVA PHARMACEUTICALS USA1994-08-31ANDA074368_001, ANDA074368_002, ANDA074368_003
5ANDA074501NADOLOLSANDOZ INC1995-11-09ANDA074501_001, ANDA074501_002, ANDA074501_003
6ANDA201893NADOLOLORION CORP ORION PHARMA2015-09-16ANDA201893_001, ANDA201893_002
7NDA018063CORGARDUS WORLD MEDS LLCNDA018063_001, NDA018063_002, NDA018063_003, NDA018063_004, NDA018063_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074172_001RXNADOLOL (20MG)ORALTABLETFalseAB1993-10-31NADOLOL
2ANDA074172_002RXNADOLOL (40MG)ORALTABLETFalseAB1993-10-31NADOLOL
3ANDA074172_003RXNADOLOL (80MG)ORALTABLETFalseAB1993-10-31NADOLOL
4ANDA074229_001RXNADOLOL (20MG)ORALTABLETFalseAB1996-08-30NADOLOL
5ANDA074229_002RXNADOLOL (40MG)ORALTABLETFalseAB1996-08-30NADOLOL
6ANDA074255_001RXNADOLOL (80MG)ORALTABLETFalseAB1996-01-24NADOLOL
7ANDA074255_002discontinuedNADOLOL (120MG)ORALTABLETFalse1996-01-24NADOLOL
8ANDA074255_003discontinuedNADOLOL (160MG)ORALTABLETFalse1996-01-24NADOLOL
9ANDA074368_001discontinuedNADOLOL (80MG)ORALTABLETFalse1994-08-31NADOLOL
10ANDA074368_002discontinuedNADOLOL (120MG)ORALTABLETFalse1994-08-31NADOLOL
11ANDA074368_003discontinuedNADOLOL (160MG)ORALTABLETFalse1994-08-31NADOLOL
12ANDA074501_001RXNADOLOL (20MG)ORALTABLETFalseAB1995-11-09NADOLOL
13ANDA074501_002RXNADOLOL (40MG)ORALTABLETFalseAB1995-11-09NADOLOL
14ANDA074501_003RXNADOLOL (80MG)ORALTABLETFalseAB1995-11-09NADOLOL
15ANDA201893_001RXNADOLOL (40MG)ORALTABLETFalseAB2015-09-16NADOLOL
16ANDA201893_002RXNADOLOL (80MG)ORALTABLETFalseAB2015-09-16NADOLOL
17NDA018063_001RXNADOLOL (40MG)ORALTABLETFalseABCORGARD
18NDA018063_002RXNADOLOL (80MG)ORALTABLETTrueABCORGARD
19NDA018063_003discontinuedNADOLOL (120MG)ORALTABLETFalseCORGARD
20NDA018063_004discontinuedNADOLOL (160MG)ORALTABLETFalseCORGARD
21NDA018063_005RXNADOLOL (20MG)ORALTABLETFalseAB1986-10-28CORGARD

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10031ce9c-cb49-433a-aa74-8d20ca0563c0 (view SPL)NADOLOL TABLETS USPRx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2013-10-187000934235, 000934236, 000934237
20152dffb-6575-4d15-9d67-019efa6ae5f6 (view SPL)Nadolol Tablets USPprescriptionHuman PrescriptionBluepoint LaboratoriesMANUFACTURE2015-07-152680010219, 680010220, 680010221
30c6eed96-edfd-4e65-8eff-59d1ad51a59a (view SPL)NADOLOL TABLETS USPRx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-12-271422540094
40d59bbfc-52a0-4631-9be4-d361a6e61d40 (view SPL)NADOLOL TABLETS, USPprescriptionHuman PrescriptionGreenstone LlcANALYSIS, LABEL, MANUFACTURE, PACK2014-04-172597620810, 597620811, 597620812
537781219-21d0-4bc5-91c4-92aafc8ab942 (view SPL)Nadolol Tablets USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-09-281680840897
686b00a8e-f68b-4bf4-a555-d84637472cc2 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2013-08-022510790812, 510790813
7a4fc8ec9-99c6-4739-9f71-0d9062f3ebe9 (view SPL)Nadolol Tablets, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-291216950799, 216950800, 216950802
8ac3aa150-2083-4fb0-9663-e92c1dc3135a (view SPL)NADOLOL TABLETS USPRx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-05-011422540218
9c2e709d2-96a2-41ea-b5e9-9ce4ccb91f59 (view SPL)CORGARD TABLETS(nadolol tablets,USP)prescriptionHuman PrescriptionPfizer Laboratories Div Pfizer IncANALYSIS, LABEL, MANUFACTURE, PACK2013-12-098607930800, 607930801, 607930802
10c51d1463-64aa-486e-bc50-b92758be97b1 (view SPL)Nadolol Tablets USPprescriptionHuman PrescriptionSandoz Inc2013-07-2913007811181, 007811182, 007811183
11cbc3e50e-2329-4ec5-a809-439d3d77f27c (view SPL)Nadolol Tablets USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-10-023680840755, 680840763
12d04b1887-933e-4c85-9744-659fe1e56c61 (view SPL)Nadolol Tablets, USPprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2012-01-301682586034
13d208918b-a356-4924-91d9-9593981fe0a6 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-10-014548683257, 548683721, 548685295
14f1549a3d-a51a-40fa-bc97-ad5578e6f014 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-11-274003780028, 003781132, 003781171
15f3614316-c120-4d49-9306-22b42dfbc4fd (view SPL)Nadolol Tablets USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-04-011680840696, 680840707
16fc641590-db5e-4b4e-a8b1-fc812ba42825 (view SPL)NADOLOL TABLETS USPRx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2013-02-222521250081

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