Application 065364

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COLISTIMETHATE SODIUMCOLISTIMETHATE SODIUMINJECTABLE;INJECTIONEQ 150MG BASE/VIALNoNo

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
A065364-001COLISTIMETHATE SODIUMCOLISTIMETHATE SODIUMEQ 150MG BASE/VIALINJECTABLE / INJECTIONAP2008-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065364-001AP

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 22:54:322026-06A065364-001COLISTIMETHATE SODIUMEQ 150MG BASE/VIALINJECTABLE / INJECTIONAP2008-04-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065364-001AP1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ColistimethateCOLISTIMETHATE SODIUMFresenius Kabi USA, LLCab241809-0d2f-44ba-829c-26be67ee623f2020-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065364
application number: ANDA065364
ndc (product): 63323-393

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
63323-393ColistimethateCOLISTIMETHATE SODIUMFresenius Kabi USA, LLCANDACurrent
63323-393ColistimethateCOLISTIMETHATE SODIUMFresenius Kabi USA, LLCANDACurrent
63323-393ColistimethateCOLISTIMETHATE SODIUMFresenius Kabi USA, LLCANDACurrent