Methyltestosterone Oral Capsule

Brand(s)
Android, Testred
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Valeant Pharmaceuticals North America Llc (2015-04-01)
Oldest Current Product
1973-12-03
License(s)
ANDA
RxNORM
ORAL CAPSULE\METHYLTESTOSTERONE
FDAOB
ORAL\CAPSULE\METHYLTESTOSTERONE
SPL Active
ORAL\CAPSULE\METHYLTESTOSTERONE
SPL Moiety
ORAL\CAPSULE\METHYLTESTOSTERONE

product(s) by strength(s)

methyltestosterone 10 mg oral capsule

generic product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1001151408ANDAGlobal Pharmaceuticals2015-09-21METHYLTESTOSTERONEORALCAPSULEANDA2048519bed4886-fcd0-4056-be8d-5bb4d15081ce
2001870901TestredANDAValeant Pharmaceuticals North America Llc1973-12-032017-01-01METHYLTESTOSTERONEORALCAPSULEANDA08397609db5a9d-9662-4bfb-824c-9c9aaad488dc
3001870902AndroidANDAValeant Pharmaceuticals North America Llc1973-12-032017-01-01METHYLTESTOSTERONEORALCAPSULEANDA083976a9758bea-b15b-42e5-938c-03e3f042b290

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA083976TESTREDVALEANT PHARMACEUTICALS INTERNATIONALANDA083976_001
2ANDA084967METHYLTESTOSTERONETrueHEATHER DRUG CO INCANDA084967_001
3ANDA087750VIRILONTrueSTAR PHARMACEUTICALS INC1982-11-24ANDA087750_001
4ANDA204851METHYLTESTOSTERONEIMPAX LABORATORIES INC2015-09-21ANDA204851_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA083976_001RXMETHYLTESTOSTERONE (10MG)ORALCAPSULETrueABTESTRED
2ANDA084967_001discontinuedMETHYLTESTOSTERONE (10MG)ORALCAPSULEFalseMETHYLTESTOSTERONE
3ANDA087750_001discontinuedMETHYLTESTOSTERONE (10MG)ORALCAPSULEFalse1982-11-24VIRILON
4ANDA204851_001RXMETHYLTESTOSTERONE (10MG)ORALCAPSULEFalseAB2015-09-21METHYLTESTOSTERONE

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
109db5a9d-9662-4bfb-824c-9c9aaad488dc (view SPL)Testred C-IIIprescriptionHuman PrescriptionValeant Pharmaceuticals North America Llc2015-04-014001870901
29bed4886-fcd0-4056-be8d-5bb4d15081ce (view SPL)MethylTESTOSTERone Capsules USP, 10 mg CIIIprescriptionHuman PrescriptionGlobal Pharmaceuticals2015-10-0110001151408
3a9758bea-b15b-42e5-938c-03e3f042b290 (view SPL)Android C-IIIprescriptionHuman PrescriptionValeant Pharmaceuticals North America Llc2015-04-016001870902

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