Oxandrolone Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Watson Laboratories, Inc. (2012-06-05)
Oldest Current Product
2006-12-01
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\OXANDROLONE
FDAOB
ORAL\TABLET\OXANDROLONE
SPL Active
ORAL\TABLET\OXANDROLONE
SPL Moiety
ORAL\TABLET\OXANDROLONE

product(s) by strength(s)

oxandrolone 10 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005913545NDAWatson Laboratories, Inc.2007-01-01OXANDROLONEORALTABLETNDA01371852bc111a-c4a4-44fc-ac45-82e00d64f65e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002450272ANDAUpsher-Smith Laboratories, Inc.2007-03-22OXANDROLONEORALTABLETANDA0780338e6af85f-e44e-4c47-8a1a-7c5cb7893167
2498840302ANDAPar Pharmaceutical Companies, Inc.2007-08-20OXANDROLONEORALTABLETANDA077827a6f42739-5bfc-4b76-8795-e93fa58f3d29

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1545695875ANDAA-S Medication Solutions Llc2007-08-20OXANDROLONEORALTABLET498840302ANDA07782795169103-cf37-4c06-907b-bb756f50a34c
2680840425ANDAAmerican Health Packaging2015-03-30OXANDROLONEORALTABLET498840302ANDA077827b3d24364-f4fc-4aac-ac5c-651ae7f6f9b6

oxandrolone 2.5 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005913544NDAWatson Laboratories, Inc.2007-01-01OXANDROLONEORALTABLETNDA01371852bc111a-c4a4-44fc-ac45-82e00d64f65e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002450271ANDAUpsher-Smith Laboratories, Inc.2006-12-01OXANDROLONEORALTABLETANDA076761b4ba1f43-5628-4e79-a4aa-f5c466cb517a
2498840301ANDAPar Pharmaceutical Companies, Inc.2007-08-20OXANDROLONEORALTABLETANDA077827a6f42739-5bfc-4b76-8795-e93fa58f3d29

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1680840424ANDAAmerican Health Packaging2015-03-30OXANDROLONEORALTABLET498840301ANDA077827b3d24364-f4fc-4aac-ac5c-651ae7f6f9b6

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA076761OXANDROLONEUPSHER SMITH LABORATORIES INC2006-12-01ANDA076761_001
2ANDA076897OXANDROLONETrueSANDOZ INC2006-12-01ANDA076897_001, ANDA076897_002
3ANDA077249OXANDROLONETrueROXANE LABORATORIES INC2007-07-10ANDA077249_001, ANDA077249_002
4ANDA077827OXANDROLONEPAR PHARMACEUTICAL INC2007-06-22ANDA077827_001, ANDA077827_002
5ANDA078033OXANDROLONEUPSHER SMITH LABORATORIES INC2007-03-22ANDA078033_001
6NDA013718OXANDRINGEMINI LABORATORIES LLCp6576659, TO PROMOTE WEIGHT GAIN AFTER WEIGHT LOSS IN CERTAIN TYPES OF PATIENTS
p6090799, TO PROMOTE WEIGHT GAIN AFTER WEIGHT LOSS IN CERTAIN TYPES OF PATIENTS
p5872147, TO PROMOTE WEIGHT GAIN AFTER WEIGHT LOSS IN CERTAIN TYPES OF PATIENTS
p6828313, TO PROMOTE WEIGHT GAIN AFTER WEIGHT LOSS IN CERTAIN TYPES OF PATIENTS
NDA013718_001, NDA013718_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076761_001RXOXANDROLONE (2.5MG)ORALTABLETFalseAB2006-12-01OXANDROLONE
2ANDA076897_001discontinuedOXANDROLONE (2.5MG)ORALTABLETFalse2006-12-01OXANDROLONE
3ANDA076897_002discontinuedOXANDROLONE (10MG)ORALTABLETFalse2006-12-01OXANDROLONE
4ANDA077249_001discontinuedOXANDROLONE (2.5MG)ORALTABLETFalse2007-07-10OXANDROLONE
5ANDA077249_002discontinuedOXANDROLONE (10MG)ORALTABLETFalse2007-07-10OXANDROLONE
6ANDA077827_001RXOXANDROLONE (2.5MG)ORALTABLETFalseAB2007-06-22OXANDROLONE
7ANDA077827_002RXOXANDROLONE (10MG)ORALTABLETFalseAB2007-06-22OXANDROLONE
8ANDA078033_001RXOXANDROLONE (10MG)ORALTABLETFalseAB2007-03-22OXANDROLONE
9NDA013718_001RXOXANDROLONE (2.5MG)ORALTABLETFalseABOXANDRIN
10NDA013718_002RXOXANDROLONE (10MG)ORALTABLETTrueAB2001-11-05OXANDRIN

patent(s)

#idexpiration dateapplication(s)
1p5872147 (view patent)2017-12-05NDA013718
2p6090799 (view patent)2017-07-18NDA013718
3p6576659 (view patent)2017-12-05NDA013718
4p6828313 (view patent)2017-12-05NDA013718

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
152bc111a-c4a4-44fc-ac45-82e00d64f65e (view SPL)Oxandrolone (oxandrolonetablets, USP)CIII003410 Rx onlyOXANDROLONE TABLETS USP CIIIprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-06-054005913544, 005913545
28e6af85f-e44e-4c47-8a1a-7c5cb7893167 (view SPL)Oxandrolone Tablets, USP CIIIprescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-08-274002450272
395169103-cf37-4c06-907b-bb756f50a34c (view SPL)prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-111545695875
4a6f42739-5bfc-4b76-8795-e93fa58f3d29 (view SPL)prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.manufacture2011-07-144498840301, 498840302
5b3d24364-f4fc-4aac-ac5c-651ae7f6f9b6 (view SPL)Oxandrolone Tablets, USP CIIIprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-02-232680840424, 680840425
6b4ba1f43-5628-4e79-a4aa-f5c466cb517a (view SPL)Oxandrolone Tablets, USP CIIIprescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-08-275002450271

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