FDA.reportPublic FDA data

Application 016320

Type
NDA
Sponsor
STI PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYAMBUTOLETHAMBUTOL HYDROCHLORIDETABLET;ORAL100MGYesNo
002MYAMBUTOLETHAMBUTOL HYDROCHLORIDETABLET;ORAL200MGNoNo
003MYAMBUTOLETHAMBUTOL HYDROCHLORIDETABLET;ORAL400MGYesYes
004MYAMBUTOLETHAMBUTOL HYDROCHLORIDETABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-0417MyambutolEthambutol hydrochlorideA-S Medication SolutionsNDACurrent
50090-2337Ethambutol HydrochlorideEthambutol HydrochlorideA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-2399Ethambutol HydrochlorideEthambutol HydrochlorideA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-2607MyambutolEthambutol hydrochlorideA-S Medication SolutionsNDACurrent
50090-2607MyambutolEthambutol hydrochlorideA-S Medication SolutionsNDACurrent
53808-0977Ethambutol HydrochlorideETHAMBUTOL HYDROCHLORIDEState of Florida DOH Central PharmacyNDACurrent
54879-001Ethambutol HydrochlorideEthambutol HydrochlorideSTI Pharma LLCNDA AUTHORIZED GENERICCurrent
54879-001Ethambutol HydrochlorideEthambutol HydrochlorideSTI Pharma LLCNDA AUTHORIZED GENERICCurrent
54879-001Ethambutol HydrochlorideEthambutol HydrochlorideSTI Pharma LLCNDA AUTHORIZED GENERICCurrent
54879-001Ethambutol HydrochlorideEthambutol HydrochlorideSTI Pharma LLCNDA AUTHORIZED GENERICCurrent
54879-002Ethambutol HydrochlorideEthambutol HydrochlorideSTI Pharma LLCNDA AUTHORIZED GENERICCurrent
54879-002Ethambutol HydrochlorideEthambutol HydrochlorideSTI Pharma LLCNDA AUTHORIZED GENERICCurrent
54879-002Ethambutol HydrochlorideEthambutol HydrochlorideSTI Pharma LLCNDA AUTHORIZED GENERICCurrent
54879-002Ethambutol HydrochlorideEthambutol HydrochlorideSTI Pharma LLCNDA AUTHORIZED GENERICCurrent
55695-023Ethambutol HydrochlorideEthambutol HydrochlorideDepartment of State Health Services, Pharmacy BranchNDA AUTHORIZED GENERICCurrent
55695-035Ethambutol HydrochlorideEthambutol HydrochlorideDepartment of State Health Services, Pharmacy BranchNDA AUTHORIZED GENERICCurrent
68850-004Ethambutol HydrochlorideEthambutol HydrochlorideSTI PharmaNDA AUTHORIZED GENERICCurrent
68850-005Ethambutol HydrochlorideEthambutol HydrochlorideSTI PharmaNDA AUTHORIZED GENERICCurrent
68850-010MyambutolEthambutol hydrochlorideSTI Pharma, LLCNDACurrent
68850-010MyambutolEthambutol hydrochlorideSTI Pharma, LLCNDACurrent
68850-010MyambutolEthambutol hydrochlorideSTI Pharma, LLCNDACurrent
68850-012MyambutolEthambutol hydrochlorideSTI Pharma, LLCNDACurrent
68850-012MyambutolEthambutol hydrochlorideSTI Pharma, LLCNDACurrent
68850-012MyambutolEthambutol hydrochlorideSTI Pharma, LLCNDACurrent
70518-0459Ethambutol HydrochlorideEthambutol HydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-0459Ethambutol HydrochlorideEthambutol HydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2691MyambutolEthambutol hydrochlorideREMEDYREPACK INC.NDACurrent
70518-2691MyambutolEthambutol hydrochlorideREMEDYREPACK INC.NDACurrent
70518-2691MyambutolEthambutol hydrochlorideREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10884SUPPL2013-02-26
10883SUPPL2008-11-07
439SUPPL2008-11-03
33161SUPPL2004-04-05
12986SUPPL2004-03-28
33159SUPPL2003-06-10
33160SUPPL2003-02-06
12985SUPPL2003-02-06
10882SUPPL2003-02-06
438SUPPL2003-02-06