Terbutaline Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Global Pharmaceuticals (2012-11-28)
Oldest Current Product
2001-06-26
License(s)
ANDA
RxNORM
ORAL TABLET\TERBUTALINE
FDAOB
ORAL\TABLET\TERBUTALINE SULFATE
SPL Active
ORAL\TABLET\TERBUTALINE SULFATE
SPL Moiety
ORAL\TABLET\TERBUTALINE

product(s) by strength(s)

terbutaline sulfate 2.5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001152611ANDAGlobal Pharmaceuticals2001-06-26TERBUTALINE SULFATEORALTABLETANDA075877382dcebb-6e41-4335-818d-b5822e3fb884
2005271318ANDALannett Company, Inc.2005-03-25TERBUTALINE SULFATEORALTABLETANDA077152fbf54709-5857-4dbc-9233-ebd7abff88c8
3101350579ANDAMarlex Pharmaceuticals Inc2014-10-01TERBUTALINE SULFATEORALTABLETANDA07715294742710-e87e-4e1c-85ee-0a2e7a77f0de

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950122ANDARebel Distributors Corp2005-03-25TERBUTALINE SULFATEORALTABLET005271311ANDA077152879be756-991a-42c5-a381-9c8c2ad1fbdb
2422910801ANDAAvkare, Inc.2001-06-26TERBUTALINE SULFATEORALTABLET001152611ANDA075877586cbc83-85d1-cd0f-d4a2-39b20dbcc82f
3538080312ANDAState Of Florida Doh Central Pharmacy2009-07-01TERBUTALINE SULFATEORALTABLET005271318ANDA077152352e3476-2bc4-4995-9fd9-4a8864417f1a
4680840256ANDAAmerican Health Packaging2008-03-12TERBUTALINE SULFATEORALTABLET005271318ANDA077152a89dcda2-2633-4c63-a6fe-d6d7bf0cdf32

terbutaline sulfate 5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001152622ANDAGlobal Pharmaceuticals2001-06-26TERBUTALINE SULFATEORALTABLETANDA075877382dcebb-6e41-4335-818d-b5822e3fb884
2005271311ANDALannett Company, Inc.2005-03-25TERBUTALINE SULFATEORALTABLETANDA077152fbf54709-5857-4dbc-9233-ebd7abff88c8
3101350580ANDAMarlex Pharmaceuticals Inc2014-10-01TERBUTALINE SULFATEORALTABLETANDA07715294742710-e87e-4e1c-85ee-0a2e7a77f0de

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950121ANDARebel Distributors Corp2005-03-25TERBUTALINE SULFATEORALTABLET005271311ANDA077152879be756-991a-42c5-a381-9c8c2ad1fbdb
2422910802ANDAAvkare, Inc.2001-06-26TERBUTALINE SULFATEORALTABLET001152622ANDA075877586cbc83-85d1-cd0f-d4a2-39b20dbcc82f
3430630059ANDAPd-Rx Pharmaceuticals, Inc.2001-06-26TERBUTALINE SULFATEORALTABLET001152622ANDA075877ed2af9a9-8bc4-4c6a-b8df-e8fc88c93d6c
4430630558ANDAPd-Rx Pharmaceuticals, Inc.2005-03-25TERBUTALINE SULFATEORALTABLET005271311ANDA0771527474ef3d-036f-47dd-aea7-be6d1086c0e4
5680840257ANDAAmerican Health Packaging2008-03-12TERBUTALINE SULFATEORALTABLET005271311ANDA077152a89dcda2-2633-4c63-a6fe-d6d7bf0cdf32

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075877TERBUTALINE SULFATEIMPAX LABORATORIES INC2001-06-26ANDA075877_001, ANDA075877_002
2ANDA077152TERBUTALINE SULFATELANNETT HOLDINGS INC2005-03-25ANDA077152_001, ANDA077152_002
3NDA017618BRICANYLTrueSANOFI AVENTIS US LLCNDA017618_001, NDA017618_002
4NDA017849BRETHINETrueLEHIGH VALLEY TECHNOLOGIES INCNDA017849_001, NDA017849_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075877_001RXTERBUTALINE SULFATE (2.5MG)ORALTABLETFalseAB2001-06-26TERBUTALINE SULFATE
2ANDA075877_002RXTERBUTALINE SULFATE (5MG)ORALTABLETTrueAB2001-06-26TERBUTALINE SULFATE
3ANDA077152_001RXTERBUTALINE SULFATE (2.5MG)ORALTABLETFalseAB2005-03-25TERBUTALINE SULFATE
4ANDA077152_002RXTERBUTALINE SULFATE (5MG)ORALTABLETFalseAB2005-03-25TERBUTALINE SULFATE
5NDA017618_001discontinuedTERBUTALINE SULFATE (2.5MG)ORALTABLETFalseBRICANYL
6NDA017618_002discontinuedTERBUTALINE SULFATE (5MG)ORALTABLETFalseBRICANYL
7NDA017849_001discontinuedTERBUTALINE SULFATE (2.5MG)ORALTABLETFalseBRETHINE
8NDA017849_002discontinuedTERBUTALINE SULFATE (5MG)ORALTABLETFalseBRETHINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1352e3476-2bc4-4995-9fd9-4a8864417f1a (view SPL)TERBUTALINE Sulfate Tablets USPprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-05-211538080312
2382dcebb-6e41-4335-818d-b5822e3fb884 (view SPL)Terbutaline Sulfate Tablets USP, 2.5 mg and 5 mgprescriptionHuman PrescriptionGlobal Pharmaceuticals2012-11-282001152611, 001152622
3586cbc83-85d1-cd0f-d4a2-39b20dbcc82f (view SPL)Terbutaline Sulfate Tablets USP, 2.5 mg and 5 mgprescriptionHuman PrescriptionAvkare, Inc.2013-04-054422910801, 422910802
47474ef3d-036f-47dd-aea7-be6d1086c0e4 (view SPL)TERBUTALINE SULFATE TABLETS, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-04-1812430630558
5879be756-991a-42c5-a381-9c8c2ad1fbdb (view SPL)TERBUTALINE Sulfate Tablets USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-272216950121, 216950122
694742710-e87e-4e1c-85ee-0a2e7a77f0de (view SPL)Terbutaline Sulfate Tablets, USPprescriptionHuman PrescriptionMarlex Pharmaceuticals Inc2015-03-121101350579, 101350580
7a89dcda2-2633-4c63-a6fe-d6d7bf0cdf32 (view SPL)TERBUTALINE SULFATE TABLETS USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2013-07-233680840256, 680840257
8ed2af9a9-8bc4-4c6a-b8df-e8fc88c93d6c (view SPL)Terbutaline Sulfate Tablets USP, 2.5 mg and 5 mgprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-08-161430630059
9fbf54709-5857-4dbc-9233-ebd7abff88c8 (view SPL)TERBUTALINE SULFATE TABLETS, USPprescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-04-1811005271311, 005271318

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