FDA.reportPublic FDA data

Application 208610

Type
NDA
Sponsor
MELINTA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BAXDELADELAFLOXACIN MEGLUMINETABLET;ORALEQ 450MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70842-101Baxdeladelafloxacin meglumineMelinta Therapeutics, LLCNDACurrent
70842-101Baxdeladelafloxacin meglumineMelinta Therapeutics, IncNDACurrent
70842-101Baxdeladelafloxacin meglumineMelinta Therapeutics, IncNDACurrent
70842-101Baxdeladelafloxacin meglumineMelinta Therapeutics, IncNDACurrent
70842-101Baxdeladelafloxacin meglumineMelinta Therapeutics, LLCNDACurrent
70842-101Baxdeladelafloxacin meglumineMelinta Therapeutics, IncNDACurrent
70842-101Baxdeladelafloxacin meglumineMelinta Therapeutics, LLCNDACurrent
70842-101Baxdeladelafloxacin meglumineMelinta Therapeutics, IncNDACurrent
70842-101Baxdeladelafloxacin meglumineMelinta Therapeutics, LLCNDACurrent
70842-101Baxdeladelafloxacin meglumineMelinta Therapeutics, IncNDACurrent
70842-101Baxdeladelafloxacin meglumineMelinta Therapeutics, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60677SUPPL2019-10-25
60676SUPPL2019-10-25
60672SUPPL2019-10-25
58742SUPPL2019-05-16
58739SUPPL2019-05-16
58589SUPPL2019-05-07
56074SUPPL2018-10-23
56021SUPPL2018-10-19
49058ORIG2017-07-25
48769ORIG2017-06-19
48766ORIG2017-06-19