butabarbital Oral Tablet

Brand(s)
Butisol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Meda Pharmaceuticals Inc. (2015-08-12)
Oldest Current Product
1939-08-01
License(s)
NDA
RxNORM
ORAL TABLET\BUTABARBITAL
FDAOB
ORAL\TABLET\BUTABARBITAL SODIUM
SPL Active
ORAL\TABLET\BUTABARBITAL SODIUM
SPL Moiety
ORAL\TABLET\BUTABARBITAL

product(s) by strength(s)

butabarbital sodium 30 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000370113ButisolNDAMeda Pharmaceuticals Inc.1939-08-01BUTABARBITAL SODIUMORALTABLETNDA0007937883bbc0-0874-11dc-a818-0002a5d5c51b

butabarbital sodium 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000370114ButisolNDAMeda Pharmaceuticals Inc.1939-08-012015-02-28BUTABARBITAL SODIUMORALTABLETNDA0007937883bbc0-0874-11dc-a818-0002a5d5c51b

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA083325BUTABARBITAL SODIUMTrueWHITEWORTH TOWNE PAULSEN INCANDA083325_002
2ANDA083337BUTABARBITAL SODIUMTrueWHITEWORTH TOWNE PAULSEN INCANDA083337_001
3ANDA083484SODIUM BUTABARBITALTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAANDA083484_001
4ANDA083524SODIUM BUTABARBITALTrueMARSHALL PHARMACAL CORPANDA083524_001
5ANDA083606BUTABARBITAL SODIUMTrueSOLVAY PHARMACEUTICALSANDA083606_001
6ANDA083858SODIUM BUTABARBITALTrueMARSHALL PHARMACAL CORPANDA083858_001
7ANDA083896BUTABARBITAL SODIUMTrueSOLVAY PHARMACEUTICALSANDA083896_001
8ANDA083897BUTABARBITAL SODIUMTrueSOLVAY PHARMACEUTICALSANDA083897_001
9ANDA083898BUTABARBITAL SODIUMTrueSOLVAY PHARMACEUTICALSANDA083898_001
10ANDA084040SODIUM BUTABARBITALTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAANDA084040_001
11ANDA084272BUTABARBITAL SODIUMTrueSANDOZ INCANDA084272_002
12ANDA084292BUTABARBITAL SODIUMTrueSANDOZ INC1982-02-09ANDA084292_003
13ANDA084719SARISOL NO. 1TrueHALSEY DRUG CO INCANDA084719_001, ANDA084719_002
14ANDA085418SODIUM BUTABARBITALTrueHIKMA PHARMACEUTICALS LLCANDA085418_001
15ANDA085432SODIUM BUTABARBITALTrueHIKMA PHARMACEUTICALS LLCANDA085432_001
16ANDA085550BUTABARBITALTrueCM BUNDY COANDA085550_001
17ANDA085764BUTABARBITAL SODIUMTrueWATSON LABORATORIES INCANDA085764_001
18ANDA085772BUTABARBITAL SODIUMTrueWATSON LABORATORIES INCANDA085772_001
19ANDA085849SODIUM BUTABARBITALTrueLANNETT CO INCANDA085849_001
20ANDA085866SODIUM BUTABARBITALTrueLANNETT CO INCANDA085866_001
21ANDA085881SODIUM BUTABARBITALTrueLANNETT CO INCANDA085881_001
22ANDA085934BUTABARBITAL SODIUMTrueSANDOZ INCANDA085934_001
23ANDA085938BUTABARBITAL SODIUMTrueSANDOZ INCANDA085938_001
24ANDA088631BUTABARBITAL SODIUMTrueTEVA PHARMACEUTICALS USA INC1985-05-01ANDA088631_001
25ANDA088632BUTABARBITAL SODIUMTrueTEVA PHARMACEUTICALS USA INC1985-05-18ANDA088632_001
26NDA000793BUTISOL SODIUMMEDA PHARMACEUTICALS INCNDA000793_002, NDA000793_003, NDA000793_004, NDA000793_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA083325_002discontinuedBUTABARBITAL SODIUM (15MG)ORALTABLETFalseBUTABARBITAL SODIUM
2ANDA083337_001discontinuedBUTABARBITAL SODIUM (30MG)ORALTABLETFalseBUTABARBITAL SODIUM
3ANDA083484_001discontinuedBUTABARBITAL SODIUM (15MG)ORALTABLETFalseSODIUM BUTABARBITAL
4ANDA083524_001discontinuedBUTABARBITAL SODIUM (16.2MG)ORALTABLETFalseSODIUM BUTABARBITAL
5ANDA083606_001discontinuedBUTABARBITAL SODIUM (16.2MG)ORALTABLETFalseBUTABARBITAL SODIUM
6ANDA083858_001discontinuedBUTABARBITAL SODIUM (32.4MG)ORALTABLETFalseSODIUM BUTABARBITAL
7ANDA083896_001discontinuedBUTABARBITAL SODIUM (97.2MG)ORALTABLETFalseBUTABARBITAL SODIUM
8ANDA083897_001discontinuedBUTABARBITAL SODIUM (48.6MG)ORALTABLETFalseBUTABARBITAL SODIUM
9ANDA083898_001discontinuedBUTABARBITAL SODIUM (32.4MG)ORALTABLETFalseBUTABARBITAL SODIUM
10ANDA084040_001discontinuedBUTABARBITAL SODIUM (30MG)ORALTABLETFalseSODIUM BUTABARBITAL
11ANDA084272_002discontinuedBUTABARBITAL SODIUM (30MG)ORALTABLETFalseBUTABARBITAL SODIUM
12ANDA084292_003discontinuedBUTABARBITAL SODIUM (15MG)ORALTABLETFalse1982-02-09BUTABARBITAL SODIUM
13ANDA084719_001discontinuedBUTABARBITAL SODIUM (15MG)ORALTABLETFalseSARISOL NO. 1
14ANDA084719_002discontinuedBUTABARBITAL SODIUM (30MG)ORALTABLETFalseSARISOL NO. 1
15ANDA085418_001discontinuedBUTABARBITAL SODIUM (15MG)ORALTABLETFalseSODIUM BUTABARBITAL
16ANDA085432_001discontinuedBUTABARBITAL SODIUM (30MG)ORALTABLETFalseSODIUM BUTABARBITAL
17ANDA085550_001discontinuedBUTABARBITAL SODIUM (30MG)ORALTABLETFalseBUTABARBITAL
18ANDA085764_001discontinuedBUTABARBITAL SODIUM (15MG)ORALTABLETFalseBUTABARBITAL SODIUM
19ANDA085772_001discontinuedBUTABARBITAL SODIUM (30MG)ORALTABLETFalseBUTABARBITAL SODIUM
20ANDA085849_001discontinuedBUTABARBITAL SODIUM (15MG)ORALTABLETFalseSODIUM BUTABARBITAL
21ANDA085866_001discontinuedBUTABARBITAL SODIUM (30MG)ORALTABLETFalseSODIUM BUTABARBITAL
22ANDA085881_001discontinuedBUTABARBITAL SODIUM (100MG)ORALTABLETFalseSODIUM BUTABARBITAL
23ANDA085934_001discontinuedBUTABARBITAL SODIUM (30MG)ORALTABLETFalseBUTABARBITAL SODIUM
24ANDA085938_001discontinuedBUTABARBITAL SODIUM (15MG)ORALTABLETFalseBUTABARBITAL SODIUM
25ANDA088631_001discontinuedBUTABARBITAL SODIUM (30MG)ORALTABLETFalse1985-05-01BUTABARBITAL SODIUM
26ANDA088632_001discontinuedBUTABARBITAL SODIUM (15MG)ORALTABLETFalse1985-05-18BUTABARBITAL SODIUM
27NDA000793_002discontinuedBUTABARBITAL SODIUM (15MG)ORALTABLETFalseBUTISOL SODIUM
28NDA000793_003discontinuedBUTABARBITAL SODIUM (50MG)ORALTABLETFalseBUTISOL SODIUM
29NDA000793_004RXBUTABARBITAL SODIUM (30MG)ORALTABLETTrueBUTISOL SODIUM
30NDA000793_005discontinuedBUTABARBITAL SODIUM (100MG)ORALTABLETFalseBUTISOL SODIUM

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
17883bbc0-0874-11dc-a818-0002a5d5c51b (view SPL)BUTISOL SODIUMCIII(BUTABARBITAL SODIUM TABLETS, USPAND BUTABARBITAL SODIUM ORAL SOLUTION, USP)TABLETS & ORAL SOLUTIONIN-0110-13REV. 5/2015prescriptionHuman PrescriptionMeda Pharmaceuticals Inc.2015-08-126000370113, 000370114, 000370110

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