FDA.reportPublic FDA data

Application 205703

Type
NDA
Sponsor
HQ SPCLT PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINERESMOLOL HYDROCHLORIDESOLUTION;INTRAVENOUS2.5GM/250ML (10MG/ML)YesYes
002ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINERESMOLOL HYDROCHLORIDESOLUTION;INTRAVENOUS2GM/100ML (20MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44567-811Esmolol HydrochlorideEsmolol HydrochlorideWG Critical Care, LLCNDACurrent
44567-811Esmolol HydrochlorideEsmolol HydrochlorideWG Critical Care, LLCNDACurrent
44567-811Esmolol HydrochlorideEsmolol HydrochlorideWG Critical Care, LLCNDACurrent
44567-812Esmolol HydrochlorideEsmolol HydrochlorideWG Critical Care, LLCNDACurrent
44567-812Esmolol HydrochlorideEsmolol HydrochlorideWG Critical Care, LLCNDACurrent
44567-812Esmolol HydrochlorideEsmolol HydrochlorideWG Critical Care, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78406SUPPL 2024-05-06
78392SUPPL 2024-05-03
46050ORIG2016-10-20
46049ORIG2016-10-20
32706ORIG2016-04-11
40497ORIG2016-04-08
32705ORIG2014-04-16