FDA.reportPublic FDA data

Application 006134

Type
NDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002DOLOPHINE HYDROCHLORIDEMETHADONE HYDROCHLORIDETABLET;ORAL5MGYesYes
004DOLOPHINE HYDROCHLORIDEMETHADONE HYDROCHLORIDESYRUP;ORAL10MG/30MLNoNo
010DOLOPHINE HYDROCHLORIDEMETHADONE HYDROCHLORIDETABLET;ORAL10MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N006134-002DOLOPHINE HYDROCHLORIDEMETHADONE HYDROCHLORIDE5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N006134-004DOLOPHINE HYDROCHLORIDEMETHADONE HYDROCHLORIDE10MG/30MLSYRUP / ORALApproved before 1982
N006134-010DOLOPHINE HYDROCHLORIDEMETHADONE HYDROCHLORIDE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N006134-002DOLOPHINE HYDROCHLORIDE5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N006134-004DOLOPHINE HYDROCHLORIDE10MG/30MLSYRUP / ORALApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N006134-010DOLOPHINE HYDROCHLORIDE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N006134-002DOLOPHINE HYDROCHLORIDE5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N006134-004DOLOPHINE HYDROCHLORIDE10MG/30MLSYRUP / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N006134-010DOLOPHINE HYDROCHLORIDE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N006134-002DOLOPHINE HYDROCHLORIDE5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N006134-004DOLOPHINE HYDROCHLORIDE10MG/30MLSYRUP / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N006134-010DOLOPHINE HYDROCHLORIDE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N006134-002DOLOPHINE HYDROCHLORIDE5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N006134-004DOLOPHINE HYDROCHLORIDE10MG/30MLSYRUP / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N006134-010DOLOPHINE HYDROCHLORIDE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N006134-002AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N006134-010AA174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N006134-002AA13f01610625f2…
2019-12-14 00:12 UTC2019-12N006134-010AA13f01610625f2…
2019-09-15 20:21 UTC2019-09N006134-002AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09N006134-010AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07N006134-002AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07N006134-010AA1ea99ee380514…

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methadone HydrochlorideMETHADONE HYDROCHLORIDEAmerican Health Packaging540edd43-165d-4257-b989-3bccc8f54afb2026-09-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
METHADOSE DISPERSIBLEMETHADONE HYDROCHLORIDESpecGx LLC544483e6-6f9d-4371-9e93-313e54e0ea052026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDESpecGx LLC14f7b1d8-344a-4eaa-a1bf-bc1a00c3ab582026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEMajor Pharmaceuticalsdb52fdc0-765a-4fad-a8f9-ef98c6e4b8982026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.d7b30c78-c531-4dc5-9552-d68daa3210d12026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDELong Grove Pharmaceuticals, LLCf453f1b9-d46e-4be8-835d-dbeb9d98a1492026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEBreckenridge Pharmaceutical Inc13541167-95f4-4cb9-9d7d-3c1aced5c5f62026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDESpecGx LLC5baef1bf-8bf0-429c-a4ce-1c93171f3f152026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDESpecGx LLCeddf7077-02fb-4771-9823-31984f4ff2bb2026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
METHADOSEMETHADONE HYDROCHLORIDESpecGx LLC808a9d0b-720b-4034-a862-5122ff5146082026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
Methadone Hydrocloride dye-free, sugar-free, unflavoredMETHADONE HYDROCHLORIDEBryant Ranch Prepack714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe2026-04-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEAscend Laboratories, LLCf0366917-f745-4b01-a662-a98a7d80b4a02026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
Methadone Hydrocloride dye-free, sugar-free, unflavoredMETHADONE HYDROCHLORIDEBryant Ranch Prepackf9dad5d5-3417-4992-99ee-6550f81add6b2026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEVistaPharm, LLC7ff89589-149c-4007-8144-5f60131b8c332026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.d0e6a966-179a-45e0-8444-4c1b8523f8d22026-03-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USAe72841bf-364b-49b1-8e69-7e26ddcd26572026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEVistaPharm, LLCd5bd3e97-b3f6-4bc2-9fb7-02921be35cdb2026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
Methadone Hydrocloride dye-free, sugar-free, unflavoredMETHADONE HYDROCHLORIDELannett Company, Inc.0955ea4a-c6b8-431f-ba42-9641b5b102ea2026-01-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEMylan Institutional LLC092d78eb-6423-495c-bf0d-e6532bea71382025-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEVistaPharm, LLC4c8b541c-33e8-4969-b258-af150808d46e2025-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-4218DOLOPHINEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4218DOLOPHINEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4218DOLOPHINEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4218DOLOPHINEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4219DOLOPHINEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4219DOLOPHINEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4219DOLOPHINEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4219DOLOPHINEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4570METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4570METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4570METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4570METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.NDACurrent
0054-4570METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.NDACurrent
0054-4571METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4571METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4571METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-4571METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.NDACurrent
0054-4571METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.NDACurrent
0054-8553METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-8553METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-8553METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-8553METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.NDACurrent
0054-8553METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.NDACurrent
0054-8554METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-8554METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-8554METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp.NDACurrent
0054-8554METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.NDACurrent
0054-8554METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.NDACurrent
35356-834METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-834METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-834METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-834METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-834METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-835METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-835METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-835METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-835METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-835METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
35356-835METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCNDACurrent
61919-670METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEDIRECT RXNDACurrent
61919-670METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEDirect_RxNDACurrent
61919-670METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEDirect_RxNDACurrent
61919-670METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEDirect_RxNDACurrent
71335-0119METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEBryant Ranch PrepackNDACurrent
71335-0119METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEBryant Ranch PrepackNDACurrent
71335-1106METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEBryant Ranch PrepackNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67723SUPPL2021-06-07
67675SUPPL2021-06-03
67672SUPPL2021-06-03
60348SUPPL2019-10-08
60301SUPPL2019-10-08
60300SUPPL2019-10-08
55819SUPPL2018-10-05
55818SUPPL2018-10-05
55643SUPPL2018-09-28
55642SUPPL2018-09-28
52282SUPPL2018-02-02
52253SUPPL2018-02-01
48581SUPPL2017-05-31
46275SUPPL2016-12-20
46274SUPPL2016-12-20
46196SUPPL2016-12-19
46195SUPPL2016-12-19
45458SUPPL2016-10-04
28SUPPL2016-04-22
74SUPPL2015-06-29
10682SUPPL2015-04-07
75SUPPL2015-04-03
27SUPPL2014-08-20
26SUPPL2014-04-17
32939SUPPL2014-04-16
25SUPPL2013-04-16
10681SUPPL2012-07-12
44437ORIG2012-07-11
73SUPPL2012-07-11
72SUPPL2012-07-11
43994ORIG2009-08-12
24SUPPL2006-12-04
32938SUPPL2006-11-21
20008SUPPL2006-11-17