FDA.reportPublic FDA data

Application 050682

Type
NDA
Sponsor
RECORDATI RARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COSMEGENDACTINOMYCININJECTABLE;INJECTION0.5MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55292-811CosmegendactinomycinRECORDATI RARE DISEASES, INC.NDACurrent
55292-811CosmegendactinomycinRecordati Rare Diseases, Inc.NDACurrent
55292-811CosmegendactinomycinRECORDATI RARE DISEASES, INC.NDACurrent
66993-489DactinomycinDactinomycinPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-489DactinomycinDactinomycinPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-489DactinomycinDactinomycinPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56120SUPPL2018-10-26
56119SUPPL2018-10-26
55204SUPPL2018-08-17
55187SUPPL2018-08-16
30267SUPPL2012-02-07
7991SUPPL2012-02-07
39104SUPPL2012-02-06
18010SUPPL2012-02-06
18009SUPPL2009-04-03
7990SUPPL2009-03-17
7989SUPPL2005-08-19
7988SUPPL2004-12-06
7987SUPPL2003-03-26
30266SUPPL2002-10-28