Flutamide Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Ivax Pharmaceuticals, Inc. (2012-08-31)
Oldest Current Product
2001-09-18
License(s)
ANDA
RxNORM
ORAL CAPSULE\FLUTAMIDE
FDAOB
ORAL\CAPSULE\FLUTAMIDE
SPL Active
ORAL\CAPSULE\FLUTAMIDE
SPL Moiety
ORAL\CAPSULE\FLUTAMIDE

product(s) by strength(s)

flutamide 125 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001724960ANDAIvax Pharmaceuticals, Inc.2001-09-19FLUTAMIDEORALCAPSULEANDA075780bae781d4-7101-4008-9af2-6e76b5e1c408
2005912466ANDAWatson Laboratories, Inc.2011-07-28FLUTAMIDEORALCAPSULEANDA075820d037fb0c-881f-43d2-8693-aa1342d0130a
3498840753ANDAPar Pharmaceutical Companies, Inc.2001-09-18FLUTAMIDEORALCAPSULEANDA0752988b5974d2-0f00-4201-a810-01320ac0cf13

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1604290272ANDAGolden State Medical Supply, Inc.2001-09-18FLUTAMIDEORALCAPSULE498840753ANDA07529882bb75cc-0d36-44ab-9ea6-2bd26998ce0f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075298FLUTAMIDEPAR PHARMACEUTICAL INC2001-09-18ANDA075298_001
2ANDA075780FLUTAMIDEIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2001-09-19ANDA075780_001
3ANDA075818FLUTAMIDETrueSANDOZ INC2001-09-18ANDA075818_001
4ANDA075820FLUTAMIDEACTAVIS LABORATORIES FL INC2001-09-18ANDA075820_001
5ANDA076224FLUTAMIDEMYLAN PHARMACEUTICALS INC2003-05-09ANDA076224_001
6NDA018554EULEXINTrueSCHERING CORP SUB SCHERING PLOUGH CORP1989-01-27NDA018554_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075298_001RXFLUTAMIDE (125MG)ORALCAPSULEFalseAB2001-09-18FLUTAMIDE
2ANDA075780_001RXFLUTAMIDE (125MG)ORALCAPSULETrueAB2001-09-19FLUTAMIDE
3ANDA075818_001discontinuedFLUTAMIDE (125MG)ORALCAPSULEFalse2001-09-18FLUTAMIDE
4ANDA075820_001RXFLUTAMIDE (125MG)ORALCAPSULEFalseAB2001-09-18FLUTAMIDE
5ANDA076224_001RXFLUTAMIDE (125MG)ORALCAPSULEFalseAB2003-05-09FLUTAMIDE
6NDA018554_001discontinuedFLUTAMIDE (125MG)ORALCAPSULEFalse1989-01-27EULEXIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
182bb75cc-0d36-44ab-9ea6-2bd26998ce0f (view SPL)Flutamide Capsules, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-011604290272
28b5974d2-0f00-4201-a810-01320ac0cf13 (view SPL)prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.2011-11-034498840753
3bae781d4-7101-4008-9af2-6e76b5e1c408 (view SPL)FLUTAMIDE CAPSULES USPprescriptionHuman PrescriptionIvax Pharmaceuticals, Inc.2012-08-315001724960
4d037fb0c-881f-43d2-8693-aa1342d0130a (view SPL)Flutamide Capsules USPprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-09-274005912466

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