Thalidomide Oral Capsule

Brand(s)
Thalomid
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Celgene Corporation (2015-08-12)
Oldest Current Product
2003-06-20
License(s)
NDA
RxNORM
ORAL CAPSULE\THALIDOMIDE
FDAOB
ORAL\CAPSULE\THALIDOMIDE
SPL Active
ORAL\CAPSULE\THALIDOMIDE
SPL Moiety
ORAL\CAPSULE\THALIDOMIDE

product(s) by strength(s)

thalidomide 100 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1595720210ThalomidNDACelgene Corporation2003-06-20THALIDOMIDEORALCAPSULENDA0207852eda833b-1357-4ed4-a093-194524fcb061

thalidomide 150 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1595720215ThalomidNDACelgene Corporation2007-03-20THALIDOMIDEORALCAPSULENDA0207852eda833b-1357-4ed4-a093-194524fcb061

thalidomide 200 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1595720220ThalomidNDACelgene Corporation2003-06-20THALIDOMIDEORALCAPSULENDA0207852eda833b-1357-4ed4-a093-194524fcb061

thalidomide 50 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1595720205ThalomidNDACelgene Corporation2003-06-20THALIDOMIDEORALCAPSULENDA0207852eda833b-1357-4ed4-a093-194524fcb061

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA020785THALOMIDCELGENE CORP1998-07-16p8204763, TREATMENT OF MALE PATIENT HAVING A DISEASE OR CONDITION RESPONSIVE TO A TERATOGENIC DRUG
p8589188, USE OF THALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO THALIDOMIDE
p6315720, USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA/ METHOD FOR DELIVERING A DRUG TO A PATIENT IN NEED OF THE DRUG
p8315886, TREATMENT OF MALE PATIENT HAVING A DISEASE OR CONDITION RESPONSIVE TO A TERATOGENIC DRUG
p7959566, USE OF THALIDOMIDE IN TREATMENT OF CUTANEOUS MANIFESTATIONS OF ERYTHEMA NODOSUM LEPROSUM (ENL)
p7230012, SUBSTANCE
p6561976, USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA/ APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
p6561977, USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA/ APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
p6908432, USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA/ APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
p6755784, USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA/ APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
p7435745, USE OF THALIDOMIDE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
p7141018, USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA/ APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)/ MAINTENANCE THERAPY FOR PREVENTION AND SUPRESSION OF THE CUTANEOUS MANIFESTATIONS OF ENL RECURRENCE/ ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA NODOSUM LEPROSUM (ENL)
p7874984, APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)/ MAINTENANCE THERAPY FOR PREVENTION AND SUPRESSION OF THE CUTANEOUS MANIFESTATIONS OF ENL RECURRENCE/ ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA NODOSUM LEPROSUM (ENL)/ TREATMENT OF CUTANEOUS MANIFESTATIONS OF ERYTHEMA NODOSUM LEPROSUM (ENL) IN CONNECTION WITH A SPECIAL PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)/ METHOD FOR DELIVERING A DRUG TO A PATIENT IN NEED OF THE DRUG
p8626531, USE OF THALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO THALIDOMIDE
p6045501, USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA/ APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)
p6869399, USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA/ APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.)/ MAINTENANCE THERAPY FOR PREVENTION AND SUPRESSION OF THE CUTANEOUS MANIFESTATIONS OF ENL RECURRENCE/ ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA NODOSUM LEPROSUM (ENL)
NDA020785_001, NDA020785_002, NDA020785_003, NDA020785_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020785_001RXTHALIDOMIDE (50MG)ORALCAPSULEFalse1998-07-16THALOMID
2NDA020785_002RXTHALIDOMIDE (100MG)ORALCAPSULEFalse2003-01-17THALOMID
3NDA020785_003RXTHALIDOMIDE (200MG)ORALCAPSULETrue2003-01-17THALOMID
4NDA020785_004RXTHALIDOMIDE (150MG)ORALCAPSULEFalse2007-01-10THALOMID

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6045501 (view patent)2018-08-28NDA020785, NDA021880, NDA204026lenalidomide Oral Capsule
pomalidomide Oral Capsule
2p6315720 (view patent)2020-10-23NDA020785, NDA021880, NDA204026lenalidomide Oral Capsule
pomalidomide Oral Capsule
3p6561976 (view patent)2018-08-28NDA020785, NDA021880, NDA204026lenalidomide Oral Capsule
pomalidomide Oral Capsule
4p6561977 (view patent)2020-10-23NDA020785, NDA021880, NDA204026lenalidomide Oral Capsule
pomalidomide Oral Capsule
5p6755784 (view patent)2020-10-23NDA020785, NDA021880, NDA204026lenalidomide Oral Capsule
pomalidomide Oral Capsule
6p6869399 (view patent)2020-10-23NDA020785
7p6908432 (view patent)2018-08-28NDA020785, NDA021880, NDA204026lenalidomide Oral Capsule
pomalidomide Oral Capsule
8p7141018 (view patent)2020-10-23NDA020785
9p7230012 (view patent)2023-12-09NDA020785
10p7435745 (view patent)2017-11-03NDA020785
11p7874984 (view patent)2018-08-28NDA020785
12p7959566 (view patent)2020-10-23NDA020785
13p8204763 (view patent)2018-08-28NDA020785, NDA021880, NDA204026lenalidomide Oral Capsule
pomalidomide Oral Capsule
14p8315886 (view patent)2020-10-23NDA020785, NDA021880, NDA204026lenalidomide Oral Capsule
pomalidomide Oral Capsule
15p8589188 (view patent)2018-08-28NDA020785, NDA021880, NDA204026lenalidomide Oral Capsule
pomalidomide Oral Capsule
16p8626531 (view patent)2020-10-23NDA020785, NDA021880, NDA204026lenalidomide Oral Capsule
pomalidomide Oral Capsule

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
12eda833b-1357-4ed4-a093-194524fcb061 (view SPL)These highlights do not include all the information needed to use THALOMID safely and effectively. See full prescribing information for THALOMID. THALOMID (thalidomide) capsules for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionCelgene Corporation2015-08-1212595720205, 595720210, 595720215, 595720220

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