FDA.reportPublic FDA data

Application 209556

Type
ANDA
Sponsor
TELIGENT PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATELOTION;TOPICAL0.1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51862-159HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATEMayne Pharma Inc.ANDACurrent
52565-087Hydrocortisone ButyrateHYDROCORTISONE BUTYRATETeligent Pharma, Inc.ANDACurrent
52565-087Hydrocortisone ButyrateHYDROCORTISONE BUTYRATETeligent Pharma, Inc.ANDACurrent
68788-7719Hydrocortisone ButyrateHydrocortisone Butyrate LotionPreferred Pharmaceuticals, Inc.ANDACurrent
70512-032Hydrocortisone ButyrateHydrocortisone Butyrate LotionSola PharmaceuticalsANDACurrent
70512-032Hydrocortisone ButyrateHydrocortisone Butyrate LotionSola PharmaceuticalsANDACurrent
70512-032Hydrocortisone ButyrateHydrocortisone Butyrate LotionSola PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50742ORIG2017-12-18