FDA.reportPublic FDA data

Application 018751

Type
NDA
Sponsor
ALVOGEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPECTAZOLEECONAZOLE NITRATECREAM;TOPICAL1%YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-543Econazole Nitrate CreamEconazole Nitrate CreamAlvogen Inc.NDACurrent
55700-637Econazole Nitrate CreamEconazole Nitrate CreamLake Erie Medical DBA Quality Care Products LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61615SUPPL2020-01-22
61609SUPPL2020-01-22
52281SUPPL2018-02-02
16027SUPPL2014-04-02
11316SUPPL2014-04-01