FDA.reportPublic FDA data

Application 020207

Type
NDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALKERANMELPHALAN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 50MG BASE/VIALYesNo

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

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
N020207-001ALKERANMELPHALAN HYDROCHLORIDEEQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1992-11-18

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020207-001ALKERANEQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1992-11-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020207-001ALKERANEQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1992-11-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020207-001ALKERANEQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1992-11-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020207-001ALKERANEQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1992-11-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N020207-001AP174a2ff9319b5…
2020-12-22 03:56 UTC2020-12N020207-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020207-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020207-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N020207-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020207-001AP1ea99ee380514…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Melphalan hydrochlorideMELPHALAN HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2c18beeb-7bd4-4591-94cb-9d7156c1b8e02026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELPHALAN HYDROCHLORIDE
MelphalanMELPHALAN HYDROCHLORIDEFresenius Kabi USA, LLCe9c2efee-173d-4795-96d8-7aae5b3a30732026-01-14Warnings, Adverse reactionsName fallback
generic name: MELPHALAN HYDROCHLORIDE
Melphalan HydrochlorideMELPHALAN HYDROCHLORIDEArthur Group LLC2254450e-4803-b947-e063-6394a90a46242026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELPHALAN HYDROCHLORIDE
Melphalan hydrochlorideMELPHALAN HYDROCHLORIDEBPI Labs LLCdab93975-0587-4f12-848c-9130bb02d0362025-12-05Warnings, Adverse reactionsName fallback
generic name: MELPHALAN HYDROCHLORIDE
Melphalan HydrochlorideMELPHALAN HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.91948ff9-6070-485b-b4b7-3cb477c1b24c2024-07-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELPHALAN HYDROCHLORIDE
MELPHALAN HYDROCHLORIDEMELPHALAN HYDROCHLORIDECamber Pharmaceuticals, Inc.24006cbf-4e91-4bb2-9627-25b4ebc9470a2024-06-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELPHALAN HYDROCHLORIDE
Melphalan HydrochlorideMELPHALAN HYDROCHLORIDESagent Pharmaceuticals35f3d9fe-3c2f-4362-9d40-cdab014cac382024-03-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELPHALAN HYDROCHLORIDE
Melphalan HydrochlorideMELPHALAN HYDROCHLORIDEDr.Reddy's Laboratories Incbd5e4db5-8787-4428-2cb6-ef6f8a5e08af2024-02-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELPHALAN HYDROCHLORIDE
Melphalan HydrochlorideMELPHALAN HYDROCHLORIDEAvenacy Inc.8edd78a9-d762-4578-a610-28d6595f4bf32023-12-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELPHALAN HYDROCHLORIDE
Melphalan hydrochlorideMELPHALAN HYDROCHLORIDEMeitheal Pharmaceuticals Inc.d99b3865-e0f0-482a-9ec6-da642e5104ea2021-06-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELPHALAN HYDROCHLORIDE
Melphalan HydrochlorideMELPHALAN HYDROCHLORIDEMylan Institutional LLCa8bf1877-fd06-4ef6-b82d-fe0ff1956bde2020-09-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELPHALAN HYDROCHLORIDE
Melphalan hydrochlorideMELPHALAN HYDROCHLORIDEFosun Pharma USA Inc54712714-744d-4deb-83b2-694da49a92722019-07-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELPHALAN HYDROCHLORIDE
Melphalan hydrochlorideMELPHALAN HYDROCHLORIDEGland Pharma Limitedea7fbf4e-4980-4bb4-bac9-99eb6f633ba02019-06-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELPHALAN HYDROCHLORIDE
Melphalan HydrochlorideMELPHALAN HYDROCHLORIDEDr.Reddy's Laboratories Incd4705154-3050-1a5c-950f-e24b514874012018-04-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELPHALAN 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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52609-3001ALKERANmelphalan hydrochlorideApoPharma USA, Inc.NDACurrent
52609-3001ALKERANmelphalan hydrochlorideApoPharma USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
34367SUPPL2011-06-14
24575SUPPL2011-06-14
24576SUPPL2011-05-04
34368SUPPL2011-05-02
24574SUPPL2005-06-15
12318SUPPL2004-02-06
24573SUPPL2003-05-29
2167SUPPL2002-01-07