FDA.reportPublic FDA data

Application 020769

Type
NDA
Sponsor
PRECISION DERMAT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOCOID LIPOCREAMHYDROCORTISONE BUTYRATECREAM;TOPICAL0.1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16781-384Locoid LipocreamHYDROCORTISONE BUTYRATEBausch Health US, LLCNDACurrent
16781-384Locoid LipocreamHYDROCORTISONE BUTYRATEOnset Dermatologics LLCNDACurrent
16781-384Locoid LipocreamHYDROCORTISONE BUTYRATEBausch Health US, LLCNDACurrent
16781-384Locoid LipocreamHYDROCORTISONE BUTYRATEBausch Health US, LLCNDACurrent
68682-384Hydrocortisone ButyrateHYDROCORTISONE BUTYRATEOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-384Hydrocortisone ButyrateHYDROCORTISONE BUTYRATEOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-384Hydrocortisone ButyrateHYDROCORTISONE BUTYRATEOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79822SUPPL 2024-10-07
79817SUPPL 2024-10-04
13388SUPPL2014-12-19
25758SUPPL2014-11-24
25757SUPPL2009-10-26
35312SUPPL2009-10-21
3307SUPPL2006-04-24
3306SUPPL2004-08-25
41684ORIG2003-08-07