Application 091393

Type
ANDA
Sponsor
AVANTHI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL5MGNoNo
002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL10MGNoYes
003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL15MGNoNo
004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL20MGNoNo
005OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL30MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091393-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-31
A091393-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-31
A091393-003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-31
A091393-004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-31
A091393-005OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A091393-001AB
A091393-002AB
A091393-003AB
A091393-004AB
A091393-005AB

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.

Product history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091393-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07A091393-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07A091393-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07A091393-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07A091393-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091393-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091393-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091393-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091393-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091393-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091393-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091393-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091393-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091393-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091393-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-312680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A091393-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091393-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091393-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091393-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091393-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091393-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091393-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091393-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091393-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091393-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091393-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091393-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091393-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091393-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091393-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091393-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091393-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091393-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091393-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091393-005AB12680178bc6a6…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDESt. Mary's Medical Park Pharmacy3ccf459a-fb11-e137-e063-6394a90a5a802026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch Prepack685d9709-028e-4422-bf0c-fde577b718a22026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
ndc (product): 71335-1245
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEKVK-TECH,INCe73897d6-b920-4300-a564-5dbc9c8e9fe92026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
ndc (product): 10702-009
ndc (product): 10702-008
ndc (product): 10702-056
ndc (product): 10702-057
ndc (product): 10702-018
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY424fdfc7-1c92-2e62-e063-6394a90a136b2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health Packagingaa7ac2bf-d9ed-445d-b394-4d3fe39780ca2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
ndc (product): 68084-975
ndc (product): 68084-354
ndc (product): 68084-983
ndc (product): 68084-968
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY3cd01fb7-b59c-fc5d-e063-6394a90a21d22025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEDIRECT RXa8206207-ad09-83df-e053-2995a90a78b72025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
ndc (product): 72189-094
Oxycodone HCLOXYCODONE HCLDirect_Rx31189587-a2dc-e0a1-e063-6394a90ae17d2025-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
Oxycodone HydchlorideOXYCODONE HYDCHLORIDEQuality Care Products LLCb9847cc7-67a2-408d-93cf-f9cf420346dd2024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
ndc (product): 49999-899
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEQuality Care Products LLC4cadb809-157d-49cc-97b4-3276594f19d22024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
ndc (product): 55700-175
ndc (product): 55700-174
Oxycodone HydchlorideOXYCODONE HYDCHLORIDEQuality Care Products LLC28156b13-0ba9-4dc4-be24-9c3070a7e1cc2024-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
ndc (product): 35356-839
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.17f7946d-e889-b736-e063-6394a90a42e02024-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10702-008OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEKVK-TECH,INCANDACurrent
10702-009OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEKVK-TECH,INCANDACurrent
10702-018OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEKVK-TECH,INCANDACurrent
10702-056OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEKVK-TECH,INCANDACurrent
10702-057OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEKVK-TECH,INCANDACurrent
35356-839Oxycodone HydchlorideOxycodone HydchlorideLake Erie Medical DBA QuaANDACurrent
35356-839Oxycodone HydchlorideOxycodone HydchlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-839Oxycodone HydchlorideOxycodone HydchlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-839Oxycodone HydchlorideOxycodone HydchlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-839Oxycodone HydchlorideOxycodone HydchlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-899Oxycodone HydchlorideOxycodone HydchlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-899Oxycodone HydchlorideOxycodone HydchlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-899Oxycodone HydchlorideOxycodone HydchlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-174OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-174OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-174OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-175OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-509OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-509OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEQuality Care Products, LLCANDACurrent
55700-509OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEQuality Care Products, LLCANDACurrent
55700-509OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
67296-0832OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDERedPharm Drug, Inc.ANDACurrent
67296-0832OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDERedPharm Drug, Inc.ANDACurrent
67296-0832OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDERedPharm Drug, Inc.ANDACurrent
68084-354OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-354OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-354OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-968OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-968OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-968OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-975OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-975OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-975OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-983OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-983OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
68084-983OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health PackagingANDACurrent
71335-1245OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
72189-094OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEDIRECT RXANDACurrent
72189-094OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEDIRECT RXANDACurrent
72189-094OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEDIRECT RXANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76319ORIG 2023-11-03