Terbutaline Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
United Biomedical Inc., Asia (2014-09-26)
Oldest Current Product
2009-05-20
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\TERBUTALINE
FDAOB
INJECTION\INJECTION\TERBUTALINE SULFATE\rdfq
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\TERBUTALINE SULFATE
SUBCUTANEOUS\INJECTION\TERBUTALINE SULFATE
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\TERBUTALINE
SUBCUTANEOUS\INJECTION\TERBUTALINE

product(s) by strength(s)

terbutaline sulfate 1 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439746ANDAWest-Ward Pharmaceutical Corp2009-05-20TERBUTALINE SULFATESUBCUTANEOUSINJECTIONANDA078630613df3cb-4d55-4d12-ab08-a932481aaa0b
2102710101ANDAUnited Biomedical Inc., Asia2014-12-15TERBUTALINE SULFATESUBCUTANEOUSINJECTIONANDA2001222a4be57a-a3df-4aa5-be52-845b75e78b3b
3174780933ANDAAkorn2010-02-01TERBUTALINE SULFATESUBCUTANEOUSINJECTIONANDA0781514ae8fb3d-9df3-4948-bb07-6e4169521f15
4633230665ANDAApp Pharmaceuticals, Llc2011-03-10TERBUTALINE SULFATESUBCUTANEOUSINJECTION, SOLUTIONANDA076887cec31032-f366-4524-9e01-63146e473b2b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840665ANDAGeneral Injecatables & Vaccines, Inc2011-11-16TERBUTALINE SULFATESUBCUTANEOUSINJECTION, SOLUTION633230665ANDA0768878265c67f-55bc-40f0-9ede-3e4b4bb178f4

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076770TERBUTALINE SULFATEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2004-04-23ANDA076770_001
2ANDA076853TERBUTALINE SULFATETrueTEVA PHARMACEUTICALS USA2004-07-20ANDA076853_001
3ANDA076887TERBUTALINE SULFATEFRESENIUS KABI USA LLC2004-05-26ANDA076887_001
4ANDA078151TERBUTALINE SULFATEAKORN INC2008-01-07ANDA078151_001
5ANDA078630TERBUTALINE SULFATEHIKMA FARMACEUTICA (PORTUGAL) SA2009-05-20ANDA078630_001
6ANDA200122TERBUTALINE SULFATEUNITED BIOMEDICAL INC2013-11-08ANDA200122_001
7NDA017466BRICANYLTrueSANOFI AVENTIS US LLCNDA017466_001
8NDA018571BRETHINETrueAAIPHARMA LLCNDA018571_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA076770_001RXTERBUTALINE SULFATE (1MG/ML)INJECTIONTrueAP2004-04-23TERBUTALINE SULFATE
2ANDA076853_001discontinuedTERBUTALINE SULFATE (1MG/ML)INJECTIONFalse2004-07-20TERBUTALINE SULFATE
3ANDA076887_001RXTERBUTALINE SULFATE (1MG/ML)INJECTIONFalseAP2004-05-26TERBUTALINE SULFATE
4ANDA078151_001RXTERBUTALINE SULFATE (1MG/ML)INJECTIONFalseAP2008-01-07TERBUTALINE SULFATE
5ANDA078630_001RXTERBUTALINE SULFATE (1MG/ML)INJECTIONFalseAP2009-05-20TERBUTALINE SULFATE
6ANDA200122_001RXTERBUTALINE SULFATE (1MG/ML)INJECTIONFalseAP2013-11-08TERBUTALINE SULFATE
7NDA017466_001discontinuedTERBUTALINE SULFATE (1MG/ML)INJECTIONFalseBRICANYL
8NDA018571_001discontinuedTERBUTALINE SULFATE (1MG/ML)INJECTIONFalseBRETHINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12a4be57a-a3df-4aa5-be52-845b75e78b3b (view SPL)TERBUTALINE SULFATE INJECTION USPprescriptionHuman PrescriptionUnited Biomedical Inc., AsiaMANUFACTURE2014-09-261102710101
24ae8fb3d-9df3-4948-bb07-6e4169521f15 (view SPL)TERBUTALINE SULFATE INJECTION, USPprescriptionHuman PrescriptionAkornANALYSIS, MANUFACTURE, REPACK2010-01-082174780933
3613df3cb-4d55-4d12-ab08-a932481aaa0b (view SPL)TERBUTALINE SULFATE INJECTION, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2012-11-266001439746
48265c67f-55bc-40f0-9ede-3e4b4bb178f4 (view SPL)Terbutaline Sulfate Injection, USP 1mg/mL 1mL single dose vialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-11-161525840665
5cec31032-f366-4524-9e01-63146e473b2b (view SPL)Terbutaline Sulfate Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2011-03-041633230665

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