Methyltestosterone Oral Tablet

Brand(s)
Methitest
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Global Pharmaceuticals (2015-04-27)
Oldest Current Product
1974-10-17
License(s)
ANDA
RxNORM
ORAL TABLET\METHYLTESTOSTERONE
FDAOB
ORAL\TABLET\METHYLTESTOSTERONE
SPL Active
ORAL\TABLET\METHYLTESTOSTERONE
SPL Moiety
ORAL\TABLET\METHYLTESTOSTERONE

product(s) by strength(s)

methyltestosterone 10 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001157037MethitestANDAGlobal Pharmaceuticals1974-10-17METHYLTESTOSTERONEORALTABLETANDA08076777bb4ef4-c10e-4acc-8225-651d003f4561

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA080214METHYLTESTOSTERONETruePRIVATE FORMULATIONS INCANDA080214_001, ANDA080214_002, ANDA080214_003
2ANDA080309METHYLTESTOSTERONETruePUREPAC PHARMACEUTICAL COANDA080309_001
3ANDA080310METHYLTESTOSTERONETruePUREPAC PHARMACEUTICAL COANDA080310_001
4ANDA080313METHYLTESTOSTERONETrueTABLICAPS INCANDA080313_001
5ANDA080767METHYLTESTOSTERONEIMPAX LABORATORIES INCANDA080767_002
6ANDA080839METHYLTESTOSTERONETrueINWOOD LABORATORIES INC SUB FOREST LABORATORIES INCANDA080839_001
7ANDA080931METHYLTESTOSTERONETrueWATSON LABORATORIES INCANDA080931_001
8ANDA080933METHYLTESTOSTERONETrueWATSON LABORATORIES INCANDA080933_001
9ANDA080973METHYLTESTOSTERONETrueINWOOD LABORATORIES INC SUB FOREST LABORATORIES INCANDA080973_001
10ANDA084241METHYLTESTOSTERONETruePARKE DAVIS DIV WARNER LAMBERT COANDA084241_001
11ANDA084244METHYLTESTOSTERONETruePARKE DAVIS DIV WARNER LAMBERT COANDA084244_001
12ANDA084310METHYLTESTOSTERONEIMPAX LABORATORIES INCANDA084310_001
13ANDA084312METHYLTESTOSTERONETrueKV PHARMACEUTICAL COANDA084312_001
14ANDA084331METHYLTESTOSTERONETrueWEST WARD PHARMACEUTICAL CORPANDA084331_001, ANDA084331_002
15ANDA084642METHYLTESTOSTERONETrueWEST WARD PHARMACEUTICAL CORPANDA084642_001
16ANDA085270METHYLTESTOSTERONETrueTABLICAPS INCANDA085270_001
17ANDA086450ANDROID 10VALEANT PHARMACEUTICALS INTERNATIONALANDA086450_001
18ANDA087092METHYLTESTOSTERONETrueLANNETT CO INC1982-11-05ANDA087092_001
19ANDA087111METHYLTESTOSTERONETrueLANNETT CO INC1983-01-27ANDA087111_001
20ANDA087147ANDROID 25VALEANT PHARMACEUTICALS INTERNATIONALANDA087147_001
21NDA003158ORETON METHYLTrueSCHERING CORP SUB SCHERING PLOUGH CORPNDA003158_001, NDA003158_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA080214_001discontinuedMETHYLTESTOSTERONE (5MG)ORALTABLETFalseMETHYLTESTOSTERONE
2ANDA080214_002discontinuedMETHYLTESTOSTERONE (10MG)ORALTABLETFalseMETHYLTESTOSTERONE
3ANDA080214_003discontinuedMETHYLTESTOSTERONE (25MG)ORALTABLETFalseMETHYLTESTOSTERONE
4ANDA080309_001discontinuedMETHYLTESTOSTERONE (10MG)ORALTABLETFalseMETHYLTESTOSTERONE
5ANDA080310_001discontinuedMETHYLTESTOSTERONE (25MG)ORALTABLETFalseMETHYLTESTOSTERONE
6ANDA080313_001discontinuedMETHYLTESTOSTERONE (10MG)ORALTABLETFalseMETHYLTESTOSTERONE
7ANDA080767_002RXMETHYLTESTOSTERONE (10MG)ORALTABLETFalseBPMETHYLTESTOSTERONE
8ANDA080839_001discontinuedMETHYLTESTOSTERONE (10MG)ORALTABLETFalseMETHYLTESTOSTERONE
9ANDA080931_001discontinuedMETHYLTESTOSTERONE (25MG)ORALTABLETFalseMETHYLTESTOSTERONE
10ANDA080933_001discontinuedMETHYLTESTOSTERONE (10MG)ORALTABLETFalseMETHYLTESTOSTERONE
11ANDA080973_001discontinuedMETHYLTESTOSTERONE (25MG)ORALTABLETFalseMETHYLTESTOSTERONE
12ANDA084241_001discontinuedMETHYLTESTOSTERONE (25MG)ORALTABLETFalseMETHYLTESTOSTERONE
13ANDA084244_001discontinuedMETHYLTESTOSTERONE (10MG)ORALTABLETFalseMETHYLTESTOSTERONE
14ANDA084310_001RXMETHYLTESTOSTERONE (25MG)ORALTABLETFalseBPMETHYLTESTOSTERONE
15ANDA084312_001discontinuedMETHYLTESTOSTERONE (10MG)ORALTABLETFalseMETHYLTESTOSTERONE
16ANDA084331_001discontinuedMETHYLTESTOSTERONE (10MG)ORALTABLETFalseMETHYLTESTOSTERONE
17ANDA084331_002discontinuedMETHYLTESTOSTERONE (25MG)ORALTABLETFalseMETHYLTESTOSTERONE
18ANDA084642_001discontinuedMETHYLTESTOSTERONE (25MG)ORALTABLETFalseMETHYLTESTOSTERONE
19ANDA085270_001discontinuedMETHYLTESTOSTERONE (25MG)ORALTABLETFalseMETHYLTESTOSTERONE
20ANDA086450_001RXMETHYLTESTOSTERONE (10MG)ORALTABLETFalseBPANDROID 10
21ANDA087092_001discontinuedMETHYLTESTOSTERONE (10MG)ORALTABLETFalse1982-11-05METHYLTESTOSTERONE
22ANDA087111_001discontinuedMETHYLTESTOSTERONE (25MG)ORALTABLETFalse1983-01-27METHYLTESTOSTERONE
23ANDA087147_001RXMETHYLTESTOSTERONE (25MG)ORALTABLETFalseBPANDROID 25
24NDA003158_001discontinuedMETHYLTESTOSTERONE (10MG)ORALTABLETFalseORETON METHYL
25NDA003158_002discontinuedMETHYLTESTOSTERONE (25MG)ORALTABLETFalseORETON METHYL

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
177bb4ef4-c10e-4acc-8225-651d003f4561 (view SPL)METHITEST (Methyltestosterone) Tablets, USP CIIIprescriptionHuman PrescriptionGlobal Pharmaceuticals2015-04-276001157037

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