FDA.reportPublic FDA data

Application 212429

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDESOLUTION;ORAL5MG/5MLNoNo
002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDESOLUTION;ORAL100MG/5MLNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212429-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2020-01-27
A212429-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORAL2020-01-27

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 22:54:322026-06A212429-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2020-01-27a50c72e98297…
2026-08-01 22:54:322026-06A212429-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORAL2020-01-27a50c72e98297…

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
Oxycodone Hydrochloride Oral SolutionOXYCODONE HYDROCHLORIDE ORAL SOLUTIONAurolife Pharma, LLC0b3fa92e-8351-4401-860d-4bba8a7155e62024-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212429
application number: ANDA212429
ndc (product): 13107-262
ndc (product): 13107-261

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13107-261Oxycodone Hydrochloride Oral SolutionOxycodone Hydrochloride Oral SolutionAurolife Pharma, LLCANDACurrent
13107-262Oxycodone Hydrochloride Oral SolutionOxycodone Hydrochloride Oral SolutionAurolife Pharma, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76470ORIG 2023-11-07