Dapsone Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Jacobus Pharmaceutical Company, Inc. (2011-07-11)
Oldest Current Product
2005-12-16
License(s)
ANDA
RxNORM
ORAL TABLET\DAPSONE
FDAOB
ORAL\TABLET\DAPSONE
SPL Active
ORAL\TABLET\DAPSONE
SPL Moiety
ORAL\TABLET\DAPSONE

product(s) by strength(s)

dapsone 100 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1499380101ANDAJacobus Pharmaceutical Company, Inc.1979-07-03, 2008-08-15DAPSONEORALTABLETANDA0868420792169d-c6f9-4af0-93ae-b75d710c47a9

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490078ANDARemedyrepack Inc.2010-11-18, 2013-07-29, 2013-08-29DAPSONEORALTABLET499380101ANDA086841, ANDA0868425c6a00b4-4546-4af9-a8e7-f4722b753441, aec21561-42bd-4706-86e6-ff0e1e915079, c80a98e4-ded4-487d-9281-55865dd5c25c
2548683801ANDAPhysicians Total Care, Inc.2005-12-16DAPSONEORALTABLET499380101ANDA086842d97e6985-b508-43c0-8c1f-6dfe9cc8a528

dapsone 25 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1499380102ANDAJacobus Pharmaceutical Company, Inc.1979-07-03, 2008-08-15DAPSONEORALTABLETANDA0868410792169d-c6f9-4af0-93ae-b75d710c47a9

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548682817ANDAPhysicians Total Care, Inc.2009-04-22DAPSONEORALTABLET499380102ANDA086841d97e6985-b508-43c0-8c1f-6dfe9cc8a528

application(s)

#idtitleapplicantapproved drug
1ANDA086841DAPSONEJACOBUS PHARMACEUTICAL COANDA086841_001
2ANDA086842DAPSONEJACOBUS PHARMACEUTICAL COANDA086842_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapplication
1ANDA086841_001RXDAPSONE (25MG)ORALTABLETFalseDAPSONE
2ANDA086842_001RXDAPSONE (100MG)ORALTABLETTrueDAPSONE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10792169d-c6f9-4af0-93ae-b75d710c47a9 (view SPL)DAPSONE Tablets, USP 25 mg & 100 mgprescriptionHuman PrescriptionJacobus Pharmaceutical Company, Inc.2011-07-114499380101, 499380102
25c6a00b4-4546-4af9-a8e7-f4722b753441 (view SPL)DAPSONE Tablets, USP 25 mg & 100 mgprescriptionHuman PrescriptionRemedyrepack Inc.2013-07-292493490078
3aec21561-42bd-4706-86e6-ff0e1e915079 (view SPL)DAPSONE Tablets, USP 25 mg & 100 mgprescriptionHuman PrescriptionRemedyrepack Inc.2013-08-292493490078
4c80a98e4-ded4-487d-9281-55865dd5c25c (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2010-11-1891493490078
5d97e6985-b508-43c0-8c1f-6dfe9cc8a528 (view SPL)DAPSONE Tablets, USP 25 mg & 100 mgprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-06-152548682817, 548683801

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