Tolazamide Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2009-12-15)
Oldest Current Product
2010-01-05
License(s)
ANDA
RxNORM
ORAL TABLET\TOLAZAMIDE
FDAOB
ORAL\TABLET\TOLAZAMIDE
SPL Active
ORAL\TABLET\TOLAZAMIDE
SPL Moiety
ORAL\TABLET\TOLAZAMIDE

product(s) by strength(s)

tolazamide 250 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780217ANDAMylan Pharmaceuticals Inc.2013-01-18TOLAZAMIDEORALTABLETANDA0702595cde1f9b-74f6-6c03-6329-20969b6f1cbb

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1552890265ANDAPd-Rx Pharmaceuticals, Inc.2010-01-05TOLAZAMIDEORALTABLET003780217ANDA070259ee2767d3-6b3d-4ea4-ae4d-3a6a0a10d3cc

tolazamide 500 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780551ANDAMylan Pharmaceuticals Inc.2013-01-18TOLAZAMIDEORALTABLETANDA0702595cde1f9b-74f6-6c03-6329-20969b6f1cbb

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070159TOLAZAMIDETruePAR PHARMACEUTICAL INC1986-01-06ANDA070159_001
2ANDA070160TOLAZAMIDETruePAR PHARMACEUTICAL INC1986-01-06ANDA070160_001
3ANDA070161TOLAZAMIDETruePAR PHARMACEUTICAL INC1986-01-06ANDA070161_001
4ANDA070162TOLAZAMIDETrueBARR LABORATORIES INC1986-01-14ANDA070162_001
5ANDA070163TOLAZAMIDETrueBARR LABORATORIES INC1986-01-14ANDA070163_001
6ANDA070164TOLAZAMIDETrueBARR LABORATORIES INC1986-01-14ANDA070164_001
7ANDA070165TOLAZAMIDETrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1986-01-10ANDA070165_001
8ANDA070166TOLAZAMIDETrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1986-01-10ANDA070166_001
9ANDA070167TOLAZAMIDETrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1986-01-10ANDA070167_001
10ANDA070168TOLAZAMIDETrueUSL PHARMA INC1986-04-02ANDA070168_001
11ANDA070169TOLAZAMIDETrueUSL PHARMA INC1986-04-02ANDA070169_001
12ANDA070242TOLAZAMIDETrueWATSON LABORATORIES INC1986-08-01ANDA070242_001
13ANDA070243TOLAZAMIDETrueWATSON LABORATORIES INC1986-08-01ANDA070243_001
14ANDA070244TOLAZAMIDETrueWATSON LABORATORIES INC1986-08-01ANDA070244_001
15ANDA070259TOLAZAMIDEMYLAN PHARMACEUTICALS INC1986-01-02ANDA070259_001, ANDA070259_003
16ANDA070289TOLAZAMIDETrueSANDOZ INC1986-03-13ANDA070289_001
17ANDA070290TOLAZAMIDETrueSANDOZ INC1986-03-13ANDA070290_001
18ANDA070513TOLAZAMIDETrueWATSON LABORATORIES INC1986-01-09ANDA070513_001
19ANDA070514TOLAZAMIDETrueWATSON LABORATORIES INC1986-01-09ANDA070514_001
20ANDA070515TOLAZAMIDETrueWATSON LABORATORIES INC1986-01-09ANDA070515_001
21ANDA070763TOLAZAMIDETrueSUPERPHARM CORP1986-06-16ANDA070763_001
22ANDA070764TOLAZAMIDETrueSUPERPHARM CORP1986-06-16ANDA070764_001
23ANDA071270TOLAZAMIDETrueINTERPHARM INC1986-09-23ANDA071270_001
24ANDA071271TOLAZAMIDETrueINTERPHARM INC1986-09-23ANDA071271_001
25ANDA071355TOLAZAMIDETrueUSL PHARMA INC1988-01-11ANDA071355_001
26ANDA071357TOLAZAMIDETrueMUTUAL PHARMACEUTICAL CO INC1987-07-16ANDA071357_001
27ANDA071358TOLAZAMIDETrueMUTUAL PHARMACEUTICAL CO INC1987-07-16ANDA071358_001
28ANDA071359TOLAZAMIDETrueMUTUAL PHARMACEUTICAL CO INC1987-07-16ANDA071359_001
29ANDA071633TOLAZAMIDETrueSANDOZ INC1987-12-09ANDA071633_001
30NDA015500TOLINASETruePHARMACIA AND UPJOHN CONDA015500_002, NDA015500_004, NDA015500_005
31NDA018894TOLAZAMIDETrueG AND W LABORATORIES INC1984-11-02NDA018894_001, NDA018894_002, NDA018894_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA070159_001discontinuedTOLAZAMIDE (100MG)ORALTABLETFalse1986-01-06TOLAZAMIDE
2ANDA070160_001discontinuedTOLAZAMIDE (250MG)ORALTABLETFalse1986-01-06TOLAZAMIDE
3ANDA070161_001discontinuedTOLAZAMIDE (500MG)ORALTABLETFalse1986-01-06TOLAZAMIDE
4ANDA070162_001discontinuedTOLAZAMIDE (100MG)ORALTABLETFalse1986-01-14TOLAZAMIDE
5ANDA070163_001discontinuedTOLAZAMIDE (250MG)ORALTABLETFalse1986-01-14TOLAZAMIDE
6ANDA070164_001discontinuedTOLAZAMIDE (500MG)ORALTABLETFalse1986-01-14TOLAZAMIDE
7ANDA070165_001discontinuedTOLAZAMIDE (100MG)ORALTABLETFalse1986-01-10TOLAZAMIDE
8ANDA070166_001discontinuedTOLAZAMIDE (250MG)ORALTABLETFalse1986-01-10TOLAZAMIDE
9ANDA070167_001discontinuedTOLAZAMIDE (500MG)ORALTABLETFalse1986-01-10TOLAZAMIDE
10ANDA070168_001discontinuedTOLAZAMIDE (250MG)ORALTABLETFalse1986-04-02TOLAZAMIDE
11ANDA070169_001discontinuedTOLAZAMIDE (500MG)ORALTABLETFalse1986-04-02TOLAZAMIDE
12ANDA070242_001discontinuedTOLAZAMIDE (100MG)ORALTABLETFalse1986-08-01TOLAZAMIDE
13ANDA070243_001discontinuedTOLAZAMIDE (250MG)ORALTABLETFalse1986-08-01TOLAZAMIDE
14ANDA070244_001discontinuedTOLAZAMIDE (500MG)ORALTABLETFalse1986-08-01TOLAZAMIDE
15ANDA070259_001RXTOLAZAMIDE (250MG)ORALTABLETFalse1986-01-02TOLAZAMIDE
16ANDA070259_003RXTOLAZAMIDE (500MG)ORALTABLETTrue1986-03-17TOLAZAMIDE
17ANDA070289_001discontinuedTOLAZAMIDE (250MG)ORALTABLETFalse1986-03-13TOLAZAMIDE
18ANDA070290_001discontinuedTOLAZAMIDE (500MG)ORALTABLETFalse1986-03-13TOLAZAMIDE
19ANDA070513_001discontinuedTOLAZAMIDE (100MG)ORALTABLETFalse1986-01-09TOLAZAMIDE
20ANDA070514_001discontinuedTOLAZAMIDE (250MG)ORALTABLETFalse1986-01-09TOLAZAMIDE
21ANDA070515_001discontinuedTOLAZAMIDE (500MG)ORALTABLETFalse1986-01-09TOLAZAMIDE
22ANDA070763_001discontinuedTOLAZAMIDE (250MG)ORALTABLETFalse1986-06-16TOLAZAMIDE
23ANDA070764_001discontinuedTOLAZAMIDE (500MG)ORALTABLETFalse1986-06-16TOLAZAMIDE
24ANDA071270_001discontinuedTOLAZAMIDE (250MG)ORALTABLETFalse1986-09-23TOLAZAMIDE
25ANDA071271_001discontinuedTOLAZAMIDE (500MG)ORALTABLETFalse1986-09-23TOLAZAMIDE
26ANDA071355_001discontinuedTOLAZAMIDE (100MG)ORALTABLETFalse1988-01-11TOLAZAMIDE
27ANDA071357_001discontinuedTOLAZAMIDE (100MG)ORALTABLETFalse1987-07-16TOLAZAMIDE
28ANDA071358_001discontinuedTOLAZAMIDE (250MG)ORALTABLETFalse1987-07-16TOLAZAMIDE
29ANDA071359_001discontinuedTOLAZAMIDE (500MG)ORALTABLETFalse1987-07-16TOLAZAMIDE
30ANDA071633_001discontinuedTOLAZAMIDE (100MG)ORALTABLETFalse1987-12-09TOLAZAMIDE
31NDA015500_002discontinuedTOLAZAMIDE (100MG)ORALTABLETFalseTOLINASE
32NDA015500_004discontinuedTOLAZAMIDE (250MG)ORALTABLETFalseTOLINASE
33NDA015500_005discontinuedTOLAZAMIDE (500MG)ORALTABLETFalseTOLINASE
34NDA018894_001discontinuedTOLAZAMIDE (100MG)ORALTABLETFalse1984-11-02TOLAZAMIDE
35NDA018894_002discontinuedTOLAZAMIDE (250MG)ORALTABLETFalse1984-11-02TOLAZAMIDE
36NDA018894_003discontinuedTOLAZAMIDE (500MG)ORALTABLETFalse1984-11-02TOLAZAMIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15cde1f9b-74f6-6c03-6329-20969b6f1cbb (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2009-12-155003780217, 003780551
2ee2767d3-6b3d-4ea4-ae4d-3a6a0a10d3cc (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-12-152552890265

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