FDA.reportPublic FDA data

Application 209276

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL5MGNoNo
002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL10MGNoNo
003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL20MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209276-001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORAL2018-10-25
A209276-002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORAL2018-10-25
A209276-003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORAL2018-10-25

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 22:54:322026-06A209276-001METHYLPHENIDATE HYDROCHLORIDE5MGTABLET / ORAL2018-10-25a50c72e98297…
2026-08-01 22:54:322026-06A209276-002METHYLPHENIDATE HYDROCHLORIDE10MGTABLET / ORAL2018-10-25a50c72e98297…
2026-08-01 22:54:322026-06A209276-003METHYLPHENIDATE HYDROCHLORIDE20MGTABLET / ORAL2018-10-25a50c72e98297…

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
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAurolife Pharma, LLC35be77db-fbe3-487e-a220-a08a11aaec282025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209276
application number: ANDA209276
ndc (product): 13107-382
ndc (product): 13107-380
ndc (product): 13107-381

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
13107-380Methylphenidate HydrochlorideMethylphenidate HydrochlorideAurolife Pharma, LLCANDACurrent
13107-380Methylphenidate HydrochlorideMethylphenidate HydrochlorideAurolife Pharma, LLCANDACurrent
13107-381Methylphenidate HydrochlorideMethylphenidate HydrochlorideAurolife Pharma, LLCANDACurrent
13107-381Methylphenidate HydrochlorideMethylphenidate HydrochlorideAurolife Pharma, LLCANDACurrent
13107-382Methylphenidate HydrochlorideMethylphenidate HydrochlorideAurolife Pharma, LLCANDACurrent
13107-382Methylphenidate HydrochlorideMethylphenidate HydrochlorideAurolife Pharma, LLCANDACurrent