FDA.reportPublic FDA data

Application 012770

Type
NDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VOSOL HCACETIC ACID, GLACIAL; HYDROCORTISONESOLUTION/DROPS;OTIC2%;1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0095-0201VoSoL HChydrocortisone and acetic acidECR Pharmaceuticals Co., Inc.NDACurrent
50383-901hydrocortisone and acetic acidhydrocortisone and acetic acidHi-Tech Pharmacal Co., Inc.NDACurrent
50383-901hydrocortisone and acetic acidhydrocortisone and acetic acidHi-Tech Pharmacal Co., Inc.NDACurrent
50383-901hydrocortisone and acetic acidhydrocortisone and acetic acidAkorn Operating Company LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80521SUPPL 2025-03-14
80491SUPPL 2024-12-04
10821SUPPL2016-07-18
340SUPPL2016-07-18