FDA.reportPublic FDA data

Application 211639

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMPHETAMINE SULFATEAMPHETAMINE SULFATETABLET;ORAL5MGNoNo
002AMPHETAMINE SULFATEAMPHETAMINE 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
A211639-001AMPHETAMINE SULFATEAMPHETAMINE SULFATE5MGTABLET / ORALAA2019-04-17
A211639-002AMPHETAMINE SULFATEAMPHETAMINE SULFATE10MGTABLET / ORALAA2019-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211639-001AA
A211639-002AA

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 22:54:322026-06A211639-001AMPHETAMINE SULFATE5MGTABLET / ORALAA2019-04-17a50c72e98297…
2026-08-01 22:54:322026-06A211639-002AMPHETAMINE SULFATE10MGTABLET / ORALAA2019-04-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211639-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A211639-002AA1a50c72e98297…

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
Amphetamine SulfateAMPHETAMINE SULFATEAurolife Pharma, LLC20735c2e-6304-425f-a4e4-584f6f90d6a02024-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211639
application number: ANDA211639
ndc (product): 13107-259
ndc (product): 13107-260

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13107-259Amphetamine SulfateAmphetamine SulfateAurolife Pharma, LLCANDACurrent
13107-259Amphetamine SulfateAmphetamine SulfateAurolife Pharma, LLCANDACurrent
13107-259Amphetamine SulfateAmphetamine SulfateAurolife Pharma, LLCANDACurrent
13107-259Amphetamine SulfateAmphetamine SulfateAurolife Pharma, LLCANDACurrent
13107-260Amphetamine SulfateAmphetamine SulfateAurolife Pharma, LLCANDACurrent
13107-260Amphetamine SulfateAmphetamine SulfateAurolife Pharma, LLCANDACurrent
13107-260Amphetamine SulfateAmphetamine SulfateAurolife Pharma, LLCANDACurrent
13107-260Amphetamine SulfateAmphetamine SulfateAurolife Pharma, LLCANDACurrent