FDA.reportPublic FDA data

Application 201849

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLUCAGONGLUCAGON HYDROCHLORIDEPOWDER;INTRAMUSCULAR, INTRAVENOUSEQ 1MG BASE/VIALYesYes
002GLUCAGONGLUCAGON HYDROCHLORIDEPOWDER;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSEQ 1MG BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51662-1498GLUCAGONGLUCAGONHF Acquisition Co LLC, DBA HealthFirstNDACurrent
63323-582GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-582GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-593GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-593GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-593GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-593GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-594GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-594GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-594GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-594GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-594GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-596GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-596GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-596GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-596GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-596GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-596GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-596GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-596GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent
63323-596GlucagonGlucagonFresenius Kabi USA, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83367SUPPL 2025-09-17
83364SUPPL 2025-09-17
71574SUPPL2022-07-15
71557SUPPL2022-07-15
68263SUPPL2021-08-02
68257SUPPL2021-08-02
59975SUPPL2019-09-11
59966SUPPL2019-09-11
22863ORIG2016-05-25
19036SUPPL2015-12-02
9934SUPPL2015-12-02
32142ORIG2015-05-13