FDA.reportPublic FDA data

Application 087393

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDESOLUTION;ORAL5MG/5MLNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A087393-001METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A087393-001AA

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A087393-001METHADONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A087393-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A087393-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087393-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087393-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A087393-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087393-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087393-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087393-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087393-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087393-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087393-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087393-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087393-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087393-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087393-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087393-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087393-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087393-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087393-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087393-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087393-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087393-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087393-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A087393-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087393-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087393-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087393-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A087393-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A087393-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087393-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087393-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087393-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087393-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087393-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087393-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087393-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A087393-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A087393-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087393-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087393-001AA1f41ea6bd6efb…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methadone HydrochlorideMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.8c363f90-c378-48ae-abbc-aeb25c9bf5cb2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087393
application number: ANDA087393
ndc (product): 0054-3555
Methadone HydrochlorideMETHADONE HYDROCHLORIDEPrecision Dose, Inc.cbc42334-8783-4572-b8da-8c7451d140772025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087393
application number: ANDA087393
ndc (product): 68094-031
Methadone HydrochlorideMETHADONE HYDROCHLORIDEAmerican Health Packagingf935effe-e5b2-4bf7-bbde-6e80bb99076f2025-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087393
application number: ANDA087393
Methadone HydrochlorideMETHADONE HYDROCHLORIDEPrecision Dose, Inc.e980d666-d74d-4358-a3b7-c6accb15eba62025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087393
application number: ANDA087393

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3555Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3555Methadone HydrochlorideMethadone HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3555Methadone HydrochlorideMethadone HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3555Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3555Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3555Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3555Methadone HydrochlorideMethadone HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
17856-3554Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-3554Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-3554Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-3554Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-3555Methadone HydrochlorideMethadone HydrochlorideAtlantic Biologicals CorpsANDACurrent
17856-3555Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-3555Methadone HydrochlorideMethadone HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
68094-031Methadone HydrochlorideMethadone HydrochloridePrecision Dose, Inc.ANDACurrent
68094-031Methadone HydrochlorideMethadone HydrochloridePrecision Dose, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44543ORIG2015-06-30
39594SUPPL2014-05-06