FDA.reportPublic FDA data

Application 014602

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CELESTONE SOLUSPANBETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATEINJECTABLE;INJECTION3MG/ML;EQ 3MG BASE/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-4320CELESTONE SOLUSPANBetamethasone Acetate and Betamethasone Sodium PhosphateMerck Sharp & Dohme Corp.NDACurrent
0085-4320CELESTONE SOLUSPANBetamethasone Acetate and Betamethasone Sodium PhosphateMerck Sharp & Dohme Corp.NDACurrent
0085-4320CELESTONE SOLUSPANBetamethasone Acetate and Betamethasone Sodium PhosphateMerck Sharp & Dohme Corp.NDACurrent
51754-5060Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateExela Pharma Sciences, LLCNDA AUTHORIZED GENERICCurrent
51754-5060Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateExela Pharma Sciences, LLCNDA AUTHORIZED GENERICCurrent
51754-5060Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateExela Pharma Sciences, LLCNDA AUTHORIZED GENERICCurrent
51754-5060Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateExela Pharma Sciences, LLCNDA AUTHORIZED GENERICCurrent
51754-5060Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateExela Pharma Sciences, LLCNDA AUTHORIZED GENERICCurrent
70518-1879CELESTONE SOLUSPANBetamethasone Acetate and Betamethasone Sodium PhosphateREMEDYREPACK INC.NDACurrent
70518-2952Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2952Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone AcetateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
78206-118CELESTONE SOLUSPANBetamethasone Acetate and Betamethasone Sodium PhosphateOrganon LLCNDACurrent
78206-118CELESTONE SOLUSPANBetamethasone Acetate and Betamethasone Sodium PhosphateOrganon LLCNDACurrent
78206-118CELESTONE SOLUSPANBetamethasone Acetate and Betamethasone Sodium PhosphateOrganon LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79030SUPPL 2024-07-09
79002SUPPL 2024-07-09
78713SUPPL 2024-06-07
78679SUPPL 2024-06-06
72062SUPPL2022-09-10
72022SUPPL2022-09-08
53653SUPPL2018-04-12
53651SUPPL2018-04-11
52632SUPPL2018-02-14
52562SUPPL2018-02-12
12067SUPPL2015-02-06
10844SUPPL2015-02-05
33123SUPPL2014-07-08
379SUPPL2014-07-08
40694SUPPL2013-06-04
378SUPPL2008-06-30
33122SUPPL2008-06-26
12066SUPPL2006-07-21