Thyroxine Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
App Pharmaceuticals, Llc (2015-03-18)
Oldest Current Product
2011-06-24
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\THYROXINE
FDAOB
INTRAVENOUS\POWDER\LEVOTHYROXINE SODIUM
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\LEVOTHYROXINE SODIUM ANHYDROUS
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\LEVOTHYROXINE

product(s) by strength(s)

levothyroxine sodium 0.02 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230649NDAApp Pharmaceuticals, Llc2011-06-24LEVOTHYROXINE SODIUM ANHYDROUSINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA202231152d071f-d4aa-46d2-b397-61c1cabdd86d, ce990712-49c1-4f66-9ee4-c770e8ec394c, f88f44d8-2f18-4155-9d78-6323d19fbafe

levothyroxine sodium 0.04 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230647NDAApp Pharmaceuticals, Llc2011-06-24LEVOTHYROXINE SODIUM ANHYDROUSINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA202231ce990712-49c1-4f66-9ee4-c770e8ec394c, f88f44d8-2f18-4155-9d78-6323d19fbafe

levothyroxine sodium 0.1 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230648NDAApp Pharmaceuticals, Llc2011-06-24LEVOTHYROXINE SODIUM ANHYDROUSINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA202231152d071f-d4aa-46d2-b397-61c1cabdd86d, ce990712-49c1-4f66-9ee4-c770e8ec394c

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA202231LEVOTHYROXINE SODIUMFRESENIUS KABI USA LLC2011-06-24p9006289, SUBSTANCE
p9168239, SUBSTANCE
p9168238, SUBSTANCE
NDA202231_001, NDA202231_002, NDA202231_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202231_001RXLEVOTHYROXINE SODIUM (100MCG/VIAL)INTRAVENOUSPOWDERTrue2011-06-24LEVOTHYROXINE SODIUM
2NDA202231_002RXLEVOTHYROXINE SODIUM (200MCG/VIAL)INTRAVENOUSPOWDERTrue2011-06-24LEVOTHYROXINE SODIUM
3NDA202231_003RXLEVOTHYROXINE SODIUM (500MCG/VIAL)INTRAVENOUSPOWDERTrue2011-06-24LEVOTHYROXINE SODIUM

patent(s)

#idexpiration dateapplication(s)
1p9006289 (view patent)2032-10-03NDA202231
2p9168238 (view patent)2032-08-29NDA202231
3p9168239 (view patent)2032-08-29NDA202231

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1152d071f-d4aa-46d2-b397-61c1cabdd86d (view SPL)These highlights do not include all the information needed to use Levothyroxine Sodium for Injection safely and effectively. See full prescribing information for Levothyroxine Sodium for Injection. Levothyroxine Sodium for InjectionInitial U.S. Approval: 1969prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-01-131633230648, 633230649
2ce990712-49c1-4f66-9ee4-c770e8ec394c (view SPL)These highlights do not include all the information needed to use Levothyroxine Sodium for Injection safely and effectively. See full prescribing information for Levothyroxine Sodium for Injection. Levothyroxine Sodium for Injection Initial U.S. Approval: 1969prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-02-053633230647, 633230648, 633230649
3f88f44d8-2f18-4155-9d78-6323d19fbafe (view SPL)These highlights do not include all the information needed to use Levothyroxine Sodium for Injection safely and effectively. See full prescribing information for Levothyroxine Sodium for Injection. Levothyroxine Sodium for InjectionInitial U.S. Approval: 1969prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-03-182633230647, 633230649

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