FDA.reportPublic FDA data

Application 202160

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL5MGNoNo
002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL15MGNoNo
003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL30MGNoNo

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
A202160-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2012-11-19
A202160-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2012-11-19
A202160-003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2012-11-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202160-001AB
A202160-002AB
A202160-003AB

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 22:54:322026-06A202160-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2012-11-19a50c72e98297…
2026-08-01 22:54:322026-06A202160-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2012-11-19a50c72e98297…
2026-08-01 22:54:322026-06A202160-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2012-11-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202160-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202160-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A202160-003AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.bdade691-3687-3308-e053-2995a90ad6ed2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202160
application number: ANDA202160
ndc (product): 68071-2368
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEAurolife Pharma, LLC96ad4352-fff3-46a7-85de-466cc161045e2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202160
application number: ANDA202160
ndc (product): 13107-055
ndc (product): 13107-057
ndc (product): 13107-056
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack261132f9-ab96-4901-a660-a80c3e0f9d862024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202160
application number: ANDA202160
ndc (product): 71335-1361

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13107-055Oxycodone HydrochlorideOxycodone HydrochlorideAurolife Pharma, LLCANDACurrent
13107-055Oxycodone HydrochlorideOxycodone HydrochlorideAurolife Pharma, LLCANDACurrent
13107-056Oxycodone HydrochlorideOxycodone HydrochlorideAurolife Pharma, LLCANDACurrent
13107-056Oxycodone HydrochlorideOxycodone HydrochlorideAurolife Pharma, LLCANDACurrent
13107-057Oxycodone HydrochlorideOxycodone HydrochlorideAurolife Pharma, LLCANDACurrent
13107-057Oxycodone HydrochlorideOxycodone HydrochlorideAurolife Pharma, LLCANDACurrent
68071-2368Oxycodone HydrochlorideOxycodone HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
71335-1361Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1361Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76329ORIG 2023-11-03