FDA.reportPublic FDA data

Application 060613

Type
NDA
Sponsor
CASPER PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CASPORYN HCHYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATESUSPENSION/DROPS;OTIC1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N060613-001CASPORYN HCHYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICATRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N060613-001AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N060613-001CASPORYN HC1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLSUSPENSION/DROPS / OTICATRLD, RS, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N060613-001AT1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic SuspensionNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTICPreferred Pharmaceuticals, Inc.5f17fae0-c6ea-452e-b84f-066caf2a95fc2025-08-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 060613
application number: NDA060613
ndc (product): 68788-7787
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic SuspensionNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTICRising Pharma Holdings, Inc.35768adc-b578-4c2e-b461-22de3135a7892024-06-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 060613
application number: NDA060613
ndc (product): 64980-448
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic SuspensionNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTICA-S Medication Solutionsc895676f-446a-4a93-a3d2-addcce96b1082023-01-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 060613
application number: NDA060613

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64980-448Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspensionneomycin and polymyxin B sulfates and hydrocortisone oticRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
64980-448Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspensionneomycin and polymyxin B sulfates and hydrocortisone oticRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
64980-448Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspensionneomycin and polymyxin B sulfates and hydrocortisone oticRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68788-7787Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspensionneomycin and polymyxin B sulfates and hydrocortisone oticPreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68788-7787Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspensionneomycin and polymyxin B sulfates and hydrocortisone oticPreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68788-7787Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspensionneomycin and polymyxin B sulfates and hydrocortisone oticPreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
70199-011CASPORYN HCneomycin and polymyxin B sulfates and hydrocortisone oticCasper Pharma LLCNDACurrent
70199-011CASPORYN HCneomycin and polymyxin B sulfates and hydrocortisone oticCasper Pharma LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79693SUPPL 2024-09-23
79661SUPPL 2024-09-23
50819SUPPL2017-12-21