Tolbutamide Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2009-02-01)
Oldest Current Product
1989-11-01
License(s)
ANDA
RxNORM
ORAL TABLET\TOLBUTAMIDE
FDAOB
ORAL\TABLET\TOLBUTAMIDE
SPL Active
ORAL\TABLET\TOLBUTAMIDE
SPL Moiety
ORAL\TABLET\TOLBUTAMIDE

product(s) by strength(s)

tolbutamide 500 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780215ANDAMylan Pharmaceuticals Inc.1989-11-01TOLBUTAMIDEORALTABLETANDA0864453995eed8-39ec-ce5e-8cc2-062f93445c8d

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA086047TOLBUTAMIDETruePARKE DAVIS DIV WARNER LAMBERT COANDA086047_001
2ANDA086109TOLBUTAMIDETrueWATSON LABORATORIES INCANDA086109_001
3ANDA086141TOLBUTAMIDETrueALRA LABORATORIES INCANDA086141_001
4ANDA086445TOLBUTAMIDEMYLAN PHARMACEUTICALS INCANDA086445_001
5ANDA086574TOLBUTAMIDETrueSANDOZ INCANDA086574_001
6ANDA086926TOLBUTAMIDETrueDAVA PHARMACEUTICALS INCANDA086926_001
7ANDA087093TOLBUTAMIDETrueIVAX PHARMACEUTICALS INCANDA087093_001
8ANDA087121TOLBUTAMIDETrueBARR LABORATORIES INCANDA087121_001
9ANDA087318TOLBUTAMIDETrueWATSON LABORATORIES INCANDA087318_001
10ANDA087541TOLBUTAMIDETrueASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC1983-03-01ANDA087541_001
11ANDA087876TOLBUTAMIDETrueVANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO1982-04-20ANDA087876_001
12ANDA088893TOLBUTAMIDETrueSUPERPHARM CORP1984-11-19ANDA088893_001
13ANDA088950TOLBUTAMIDETruePUREPAC PHARMACEUTICAL CO1985-06-17ANDA088950_001
14ANDA089110TOLBUTAMIDETrueWATSON LABORATORIES INC1987-05-29ANDA089110_001
15ANDA089111TOLBUTAMIDETrueWATSON LABORATORIES INC1987-05-29ANDA089111_001
16NDA010670ORINASETruePHARMACIA AND UPJOHN CONDA010670_001, NDA010670_002
17NDA012678TOLBUTAMIDETrueSANDOZ INCNDA012678_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA086047_001discontinuedTOLBUTAMIDE (500MG)ORALTABLETFalseTOLBUTAMIDE
2ANDA086109_001discontinuedTOLBUTAMIDE (500MG)ORALTABLETFalseTOLBUTAMIDE
3ANDA086141_001discontinuedTOLBUTAMIDE (500MG)ORALTABLETFalseTOLBUTAMIDE
4ANDA086445_001RXTOLBUTAMIDE (500MG)ORALTABLETTrueTOLBUTAMIDE
5ANDA086574_001discontinuedTOLBUTAMIDE (500MG)ORALTABLETFalseTOLBUTAMIDE
6ANDA086926_001discontinuedTOLBUTAMIDE (500MG)ORALTABLETFalseTOLBUTAMIDE
7ANDA087093_001discontinuedTOLBUTAMIDE (500MG)ORALTABLETFalseTOLBUTAMIDE
8ANDA087121_001discontinuedTOLBUTAMIDE (500MG)ORALTABLETFalseTOLBUTAMIDE
9ANDA087318_001discontinuedTOLBUTAMIDE (500MG)ORALTABLETFalseTOLBUTAMIDE
10ANDA087541_001discontinuedTOLBUTAMIDE (500MG)ORALTABLETFalse1983-03-01TOLBUTAMIDE
11ANDA087876_001discontinuedTOLBUTAMIDE (500MG)ORALTABLETFalse1982-04-20TOLBUTAMIDE
12ANDA088893_001discontinuedTOLBUTAMIDE (500MG)ORALTABLETFalse1984-11-19TOLBUTAMIDE
13ANDA088950_001discontinuedTOLBUTAMIDE (500MG)ORALTABLETFalse1985-06-17TOLBUTAMIDE
14ANDA089110_001discontinuedTOLBUTAMIDE (250MG)ORALTABLETFalse1987-05-29TOLBUTAMIDE
15ANDA089111_001discontinuedTOLBUTAMIDE (500MG)ORALTABLETFalse1987-05-29TOLBUTAMIDE
16NDA010670_001discontinuedTOLBUTAMIDE (500MG)ORALTABLETFalseORINASE
17NDA010670_002discontinuedTOLBUTAMIDE (250MG)ORALTABLETFalseORINASE
18NDA012678_001discontinuedTOLBUTAMIDE (500MG)ORALTABLETFalseTOLBUTAMIDE

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
13995eed8-39ec-ce5e-8cc2-062f93445c8d (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2009-02-015003780215

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