Danazol Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Barr Laboratories Inc. (2013-09-26)
Oldest Current Product
1996-08-09
License(s)
ANDA
RxNORM
ORAL CAPSULE\DANAZOL
FDAOB
ORAL\CAPSULE\DANAZOL
SPL Active
ORAL\CAPSULE\DANAZOL
SPL Moiety
ORAL\CAPSULE\DANAZOL

product(s) by strength(s)

danazol 100 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005271368ANDALannett Company, Inc.2007-04-19DANAZOLORALCAPSULEANDA078214f2c9b713-aafc-49ca-866e-334d9b5c2e2d
2005550634ANDABarr Laboratories Inc.1998-06-25DANAZOLORALCAPSULEANDA074582e19acee5-ff33-45a5-bbbf-801756bc59b4

danazol 200 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005271369ANDALannett Company, Inc.2005-09-28DANAZOLORALCAPSULEANDA077246f2c9b713-aafc-49ca-866e-334d9b5c2e2d
2005550635ANDABarr Laboratories Inc.1996-08-09DANAZOLORALCAPSULEANDA074582e19acee5-ff33-45a5-bbbf-801756bc59b4

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1681512298ANDACarilion Materials Management2005-09-28DANAZOLORALCAPSULE005271369ANDA07724635a21f89-cf5f-4e8b-8400-3ef7023bc49c

danazol 50 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005271392ANDALannett Company, Inc.2007-04-19DANAZOLORALCAPSULEANDA078214f2c9b713-aafc-49ca-866e-334d9b5c2e2d
2005550633ANDABarr Laboratories Inc.1998-06-25DANAZOLORALCAPSULEANDA074582e19acee5-ff33-45a5-bbbf-801756bc59b4

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA071569DANAZOLTrueAMERICAN THERAPEUTICS INC1987-12-30ANDA071569_001
2ANDA074582DANAZOLBARR LABORATORIES INC1996-08-09ANDA074582_001, ANDA074582_002, ANDA074582_003
3ANDA077246DANAZOLLANNETT HOLDINGS INC2005-09-28ANDA077246_001
4ANDA078214DANAZOLLANNETT HOLDINGS INC2007-04-19ANDA078214_001, ANDA078214_002
5NDA017557DANOCRINETrueSANOFI AVENTIS US LLCNDA017557_002, NDA017557_003, NDA017557_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA071569_001discontinuedDANAZOL (200MG)ORALCAPSULEFalse1987-12-30DANAZOL
2ANDA074582_001RXDANAZOL (200MG)ORALCAPSULETrueAB1996-08-09DANAZOL
3ANDA074582_002RXDANAZOL (100MG)ORALCAPSULEFalseAB1998-05-29DANAZOL
4ANDA074582_003RXDANAZOL (50MG)ORALCAPSULEFalseAB1998-05-29DANAZOL
5ANDA077246_001RXDANAZOL (200MG)ORALCAPSULEFalseAB2005-09-28DANAZOL
6ANDA078214_001RXDANAZOL (50MG)ORALCAPSULEFalseAB2007-04-19DANAZOL
7ANDA078214_002RXDANAZOL (100MG)ORALCAPSULEFalseAB2007-04-19DANAZOL
8NDA017557_002discontinuedDANAZOL (200MG)ORALCAPSULEFalseDANOCRINE
9NDA017557_003discontinuedDANAZOL (50MG)ORALCAPSULEFalseDANOCRINE
10NDA017557_004discontinuedDANAZOL (100MG)ORALCAPSULEFalseDANOCRINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
135a21f89-cf5f-4e8b-8400-3ef7023bc49c (view SPL)DANAZOL CAPSULES, USP Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-01-262681512298
2e19acee5-ff33-45a5-bbbf-801756bc59b4 (view SPL)DANAZOL Capsules USPprescriptionHuman PrescriptionBarr Laboratories Inc.2013-09-266005550633, 005550634, 005550635
3f2c9b713-aafc-49ca-866e-334d9b5c2e2d (view SPL)DANAZOL CAPSULES, USPRx onlyprescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-01-2618005271368, 005271369, 005271392

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