FDA.reportPublic FDA data

Application 060304

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEOMYCIN SULFATENEOMYCIN SULFATETABLET;ORAL500MGNoYes

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
A060304-001NEOMYCIN SULFATENEOMYCIN SULFATE500MGTABLET / ORALAARS, 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
A060304-001AA

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 22:54:322026-06A060304-001NEOMYCIN SULFATE500MGTABLET / ORALAARS, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A060304-001AA1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin SulfateNEOMYCIN SULFATEREMEDYREPACK INC.461f62b9-b9ec-43f2-aee7-0895638105b82026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 060304
application number: ANDA060304
Neomycin SulfateNEOMYCIN SULFATETeva Pharmaceuticals USA, Inc.777dbfab-f83e-4738-ae1e-78619a9f82a72022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 060304
application number: ANDA060304
ndc (product): 0093-1177

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-1177Neomycin SulfateNeomycin SulfateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1177Neomycin SulfateNeomycin SulfateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1177Neomycin SulfateNeomycin SulfateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1177Neomycin SulfateNeomycin SulfateTeva Pharmaceuticals USA, Inc.ANDACurrent
63629-8352Neomycin SulfateNeomycin SulfateBryant Ranch PrepackANDACurrent
63629-8352Neomycin SulfateNeomycin SulfateBryant Ranch PrepackANDACurrent