FDA.reportPublic FDA data

Application 202893

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL5MGNoNo
002DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL10MGNoNo

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
A202893-001DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE5MGTABLET / ORALAA2013-07-31
A202893-002DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE10MGTABLET / ORALAA2013-07-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A202893-001AA
A202893-002AA

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 22:54:322026-06A202893-001DEXTROAMPHETAMINE SULFATE5MGTABLET / ORALAA2013-07-31a50c72e98297…
2026-08-01 22:54:322026-06A202893-002DEXTROAMPHETAMINE SULFATE10MGTABLET / ORALAA2013-07-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202893-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A202893-002AA1a50c72e98297…

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
DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEAurolife Pharma, LLC24163442-dd03-4066-a6ed-eb7e292b700b2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202893
application number: ANDA202893
ndc (product): 13107-036
ndc (product): 13107-035

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
13107-035DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEAurolife Pharma, LLCANDACurrent
13107-035DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEAurolife Pharma, LLCANDACurrent
13107-035DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEAurolife Pharma, LLCANDACurrent
13107-036DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEAurolife Pharma, LLCANDACurrent
13107-036DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEAurolife Pharma, LLCANDACurrent
13107-036DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEAurolife Pharma, LLCANDACurrent