FDA.reportPublic FDA data

Application 208079

Type
NDA
Sponsor
ENCORE DERMAT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SERNIVOBETAMETHASONE DIPROPIONATESPRAY;TOPICALEQ 0.05% BASE/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67857-808Sernivobetamethasone dipropionatePromius Pharma, LLCNDACurrent
68040-714Sernivobetamethasone dipropionatePrimus Pharmaceuticals, Inc.NDACurrent
68040-714Sernivobetamethasone dipropionatePrimus Pharmaceuticals, Inc.NDACurrent
68040-714Sernivobetamethasone dipropionatePrimus Pharmaceuticals, Inc.NDACurrent
69482-800Sernivobetamethasone dipropionateEncore Dermatology Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62349SUPPL2020-03-26
62311SUPPL2020-03-25
56666SUPPL2018-12-07
56617SUPPL2018-12-03
49518ORIG2017-08-23
32887ORIG2016-02-09
19983ORIG2016-02-09