FDA.reportPublic FDA data

Application 208611

Type
NDA
Sponsor
MELINTA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BAXDELADELAFLOXACIN MEGLUMINEPOWDER;INTRAVENOUSEQ 300MG BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70842-102Baxdeladelafloxacin meglumineMelinta Therapeutics, LLCNDACurrent
70842-102Baxdeladelafloxacin meglumineMelinta Therapeutics, IncNDACurrent
70842-102Baxdeladelafloxacin meglumineMelinta Therapeutics, IncNDACurrent
70842-102Baxdeladelafloxacin meglumineMelinta Therapeutics, IncNDACurrent
70842-102Baxdeladelafloxacin meglumineMelinta Therapeutics, LLCNDACurrent
70842-102Baxdeladelafloxacin meglumineMelinta Therapeutics, IncNDACurrent
70842-102Baxdeladelafloxacin meglumineMelinta Therapeutics, LLCNDACurrent
70842-102Baxdeladelafloxacin meglumineMelinta Therapeutics, IncNDACurrent
70842-102Baxdeladelafloxacin meglumineMelinta Therapeutics, LLCNDACurrent
70842-102Baxdeladelafloxacin meglumineMelinta Therapeutics, IncNDACurrent
70842-102Baxdeladelafloxacin meglumineMelinta Therapeutics, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76725SUPPL 2023-12-05
76720SUPPL 2023-12-04
76719SUPPL 2023-12-04
60679SUPPL2019-10-25
60678SUPPL2019-10-25
60673SUPPL2019-10-25
58741SUPPL2019-05-16
58740SUPPL2019-05-16
58590SUPPL2019-05-07
56075SUPPL2018-10-23
56020SUPPL2018-10-19
49059ORIG2017-07-25
48770ORIG2017-06-19
48765ORIG2017-06-19