FDA.reportPublic FDA data

Application 090895

Type
ANDA
Sponsor
EPIC 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
A090895-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-24
A090895-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-24
A090895-003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090895-001AB
A090895-002AB
A090895-003AB

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 22:54:322026-06A090895-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-24a50c72e98297…
2026-08-01 22:54:322026-06A090895-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-24a50c72e98297…
2026-08-01 22:54:322026-06A090895-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090895-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A090895-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A090895-003AB1a50c72e98297…

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 4 · 78 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEKVK-Tech, Inc.744f5d1c-7427-492c-8994-c8e817793e532026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDESt. Mary's Medical Park Pharmacy57afed61-79db-ca43-e063-6394a90a68eb2026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONEMajor Pharmaceuticals6b6db42b-9821-4aa6-8566-297037d840792026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDESt. Mary's Medical Park Pharmacy3ccf459a-fb11-e137-e063-6394a90a5a802026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch Prepack685d9709-028e-4422-bf0c-fde577b718a22026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEEywa Pharma Incc801963d-f54d-4ed5-82c4-8b278528d3dc2026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepackbb33bf7f-aa70-4e8a-91b2-4e0400dc328e2026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
OxyContinOXYCODONE HYDROCHLORIDEKnoa Pharma LLCbfdfe235-d717-4855-a3c8-a13d26dadede2026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONEAmneal Pharmaceuticals LLC094b64b3-cd32-4de5-afb6-ea00d9caad742026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack0e4dd113-87ab-4a5d-846a-446db3cfd4692026-06-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepacke84ea009-3cab-4721-bd21-1123eccce5152026-06-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEKVK-TECH,INCe73897d6-b920-4300-a564-5dbc9c8e9fe92026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDERedpharm Drug5301d432-7fca-2d72-e063-6394a90a18a42026-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack27124cdf-a3e8-474c-9c1e-6fa48f6ddc052026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONERedpharm Drug525001a6-68d8-7ef7-e063-6294a90abc5f2026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY424fdfc7-1c92-2e62-e063-6394a90a136b2026-05-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f2026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDERhodes Pharmaceuticals LLCa5162476-1217-41c0-bc7e-0a0f123f069f2026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
RoxicodoneOXYCODONE HYDROCHLORIDESpecGx LLC5a8157d3-ba20-4abf-b0d4-6ad141b31d632026-04-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepackff7f1268-ddb7-4742-beee-8b12966fe8f92026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9304ORIG2009-09-01