FDA.reportPublic FDA data

Application 050417

Type
NDA
Sponsor
CASPER PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEOSPORINBACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATEOINTMENT;OPHTHALMIC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMYesNo

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
N050417-001LUMI-SPORYNBACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982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
N050417-001AT

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 22:54:322026-06N050417-001LUMI-SPORYN400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**OINTMENT / OPHTHALMICATRLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N050417-001AT1a50c72e98297…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-754Neomycin and Polymyxin B Sulfates and Bacitracin ZincNeomycin and Polymyxin B Sulfates and Bacitracin ZincRising Pharma Holdings, Inc.NDA AUTHORIZED GENERICCurrent
57237-129Neomycin and Polymyxin B sulfates, Bacitracin zincNeomycin and Polymyxin B sulfates, Bacitracin zincCitron Pharma LLCNDACurrent
70199-010Neomycin and Polymyxin B sulfates, Bacitracin zincNeomycin and Polymyxin B sulfates, Bacitracin zincCasper Pharma LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63311SUPPL2020-05-28
63277SUPPL2020-05-22
38932SUPPL2004-05-04
30013SUPPL2004-05-04