Fluoxymesterone Oral Tablet

Brand(s)
Androxy
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Upsher-Smith Laboratories, Inc. (2014-10-06)
Oldest Current Product
1983-10-21
License(s)
ANDA
RxNORM
ORAL TABLET\FLUOXYMESTERONE
FDAOB
ORAL\TABLET\FLUOXYMESTERONE
SPL Active
ORAL\TABLET\FLUOXYMESTERONE
SPL Moiety
ORAL\TABLET\FLUOXYMESTERONE

product(s) by strength(s)

fluoxymesterone 10 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1008320086AndroxyANDAUpsher-Smith Laboratories, Inc.1983-10-21FLUOXYMESTERONEORALTABLETANDA0883425328c194-5650-4d1f-9e28-8cea038cce81

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA087196ANDROID-FTrueVALEANT PHARMACEUTICALS INTERNATIONALANDA087196_001
2ANDA088221FLUOXYMESTERONETrueVALEANT PHARMACEUTICALS INTERNATIONAL1983-05-05ANDA088221_001
3ANDA088260FLUOXYMESTERONETrueWATSON LABORATORIES INC1983-12-06ANDA088260_001
4ANDA088265FLUOXYMESTERONETrueWATSON LABORATORIES INC1983-12-06ANDA088265_001
5ANDA088309FLUOXYMESTERONETrueWATSON LABORATORIES INC1983-12-06ANDA088309_001
6ANDA088342FLUOXYMESTERONEUSL PHARMA INC1983-10-21ANDA088342_001
7NDA010611HALOTESTINTruePHARMACIA AND UPJOHN CONDA010611_002, NDA010611_006, NDA010611_010
8NDA011359ORA-TESTRYLTrueBRISTOL MYERS SQUIBBNDA011359_001, NDA011359_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA087196_001discontinuedFLUOXYMESTERONE (10MG)ORALTABLETFalseANDROID-F
2ANDA088221_001discontinuedFLUOXYMESTERONE (10MG)ORALTABLETFalse1983-05-05FLUOXYMESTERONE
3ANDA088260_001discontinuedFLUOXYMESTERONE (2MG)ORALTABLETFalse1983-12-06FLUOXYMESTERONE
4ANDA088265_001discontinuedFLUOXYMESTERONE (5MG)ORALTABLETFalse1983-12-06FLUOXYMESTERONE
5ANDA088309_001discontinuedFLUOXYMESTERONE (10MG)ORALTABLETFalse1983-12-06FLUOXYMESTERONE
6ANDA088342_001RXFLUOXYMESTERONE (10MG)ORALTABLETTrue1983-10-21FLUOXYMESTERONE
7NDA010611_002discontinuedFLUOXYMESTERONE (2MG)ORALTABLETFalseHALOTESTIN
8NDA010611_006discontinuedFLUOXYMESTERONE (5MG)ORALTABLETFalseHALOTESTIN
9NDA010611_010discontinuedFLUOXYMESTERONE (10MG)ORALTABLETFalseHALOTESTIN
10NDA011359_001discontinuedFLUOXYMESTERONE (2MG)ORALTABLETFalseORA-TESTRYL
11NDA011359_002discontinuedFLUOXYMESTERONE (5MG)ORALTABLETFalseORA-TESTRYL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15328c194-5650-4d1f-9e28-8cea038cce81 (view SPL)ANDROXY (Fluoxymesterone Tablets, USP)prescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-10-063008320086

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