Cyclophosphamide Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2014-07-11)
Oldest Current Product
1999-08-17
License(s)
ANDA
RxNORM
ORAL TABLET\CYCLOPHOSPHAMIDE
FDAOB
ORAL\TABLET\CYCLOPHOSPHAMIDE
SPL Active
ORAL\TABLET\CYCLOPHOSPHAMIDE
SPL Moiety
ORAL\TABLET\CYCLOPHOSPHAMIDE
ORAL\TABLET\CYCLOPHOSPHAMIDE: CYCLOPHOSPHAMIDE ANHYDROUS

product(s) by strength(s)

cyclophosphamide 25 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000544129ANDARoxane Laboratories, Inc1999-08-172016-07-11CYCLOPHOSPHAMIDEORALTABLETANDA0400321bd19d11-477e-4b4d-8d1d-4b376a403140

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685218ANDAPhysicians Total Care, Inc.1999-08-17CYCLOPHOSPHAMIDEORALTABLET000544129ANDA04003215d30249-4714-4b13-b8ca-5dff38424282

cyclophosphamide 50 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000544130ANDARoxane Laboratories, Inc1999-08-172016-07-11CYCLOPHOSPHAMIDEORALTABLETANDA0400321bd19d11-477e-4b4d-8d1d-4b376a403140

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685005ANDAPhysicians Total Care, Inc.1999-08-17CYCLOPHOSPHAMIDEORALTABLET000544130ANDA04003215d30249-4714-4b13-b8ca-5dff38424282

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040032CYCLOPHOSPHAMIDEROXANE LABORATORIES INC1999-08-17ANDA040032_001, ANDA040032_002
2NDA012141CYTOXANTrueBAXTER HEALTHCARE CORPNDA012141_001, NDA012141_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA040032_001RXCYCLOPHOSPHAMIDE (25MG)ORALTABLETFalse1999-08-17CYCLOPHOSPHAMIDE
2ANDA040032_002RXCYCLOPHOSPHAMIDE (50MG)ORALTABLETTrue1999-08-17CYCLOPHOSPHAMIDE
3NDA012141_001discontinuedCYCLOPHOSPHAMIDE (50MG)ORALTABLETFalseCYTOXAN
4NDA012141_002discontinuedCYCLOPHOSPHAMIDE (25MG)ORALTABLETFalseCYTOXAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
115d30249-4714-4b13-b8ca-5dff38424282 (view SPL)CYCLOPHOSPHAMIDE Tablets USP, 25 mg and 50 mgprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-01-231548685005, 548685218
21bd19d11-477e-4b4d-8d1d-4b376a403140 (view SPL)CYCLOPHOSPHAMIDE Tablets USP, 25 mg and 50 mgprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2014-07-115000544129, 000544130

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