FDA.reportPublic FDA data

Application 085861

Type
ANDA
Sponsor
ACTAVIS MID ATLANTIC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATESOLUTION;ORAL120MG/5ML;12MG/5MLNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 1982

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A085861-001ACETAMINOPHEN AND CODEINE PHOSPHATE120MG/5ML;12MG/5MLSOLUTION / ORALRLD, Approved before 1982e64feba35796…

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 3 · 55 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEPAI Holdings, LLC dba PAI Pharma95ac6875-6b14-4cde-8efb-80704e39b8d82026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.4c966d73-77c6-4514-954e-57aa06a080c62026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.1fe39679-fd58-4d2c-ba61-49d492a2b0872026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATESpecGx LLCeadc80fa-13c3-471a-a22f-6fe7e1ab290f2026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEUnit Dose Solutions, Inc.537245e8-5e2a-c3e0-e063-6394a90ac8582026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATESt. Mary's Medical Park Pharmacyeac5f350-93e5-4dc2-e053-2a95a90aed602026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATERedpharm Drug52617668-acc3-65cd-e063-6294a90ab9192026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepackff77a959-c77a-4911-8f7c-e2a3e24a63052026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepackf308fd07-f004-42de-963d-426b268bba932026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LP6980bfc5-15e4-48ec-9346-6f09f8f789002026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepacke73b17c4-9f24-4b32-8920-61c58c40a7142026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack879db1b5-6365-4151-9879-80d8a2a3cd8a2026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEEywa Pharma Inc79377617-686b-4640-b2b8-e1358cf823582026-03-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEGenus Lifesciences Inc.95a5d638-3072-4c37-a4cd-f8550328e2c62026-02-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.5c96d033-bf7c-47de-aa0d-5998b3bf4a632026-02-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEA-S Medication Solutions9ca1321e-380a-48d7-8a58-c6501858c1c02026-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEA-S Medication Solutionsdff53120-a609-4720-bd69-2391798c7dee2026-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEA-S Medication Solutions297dc9ff-e34f-434b-b1a4-4c995a5bac8b2026-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEST. MARY'S MEDICAL PARK PHARMACY48eb36ee-e9dc-a719-e063-6394a90aa85e2026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen and Codeine Phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEPreferred Pharmaceuticals Inc.55d494b1-c828-4841-8f64-75b92cd54cb62026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76216ORIG 2023-11-03