FDA.reportPublic FDA data

Application 091300

Type
ANDA
Sponsor
APOTEX CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RILUZOLERILUZOLETABLET;ORAL50MGNoNo

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
A091300-001RILUZOLERILUZOLE50MGTABLET / ORAL2013-06-18

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 UTC2022-10A091300-001RILUZOLE50MGTABLET / ORAL2013-06-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091300-001RILUZOLE50MGTABLET / ORAL2013-06-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091300-001RILUZOLE50MGTABLET / ORAL2013-06-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091300-001RILUZOLE50MGTABLET / ORAL2013-06-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A091300-001AB174a2ff9319b5…
2020-11-12 02:37 UTC2020-11A091300-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091300-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091300-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091300-001AB1ea99ee380514…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TIGLUTIKRILUZOLEItalfarmaco SPA20b7165a-eb4d-42a0-b2d8-16eff90a214e2026-07-29Name fallback
generic name: RILUZOLE
TIGLUTIKRILUZOLEEDW PHARMA, INC75d68f19-4208-109e-e053-2991aa0ac8572026-07-27Warnings, Adverse reactionsName fallback
generic name: RILUZOLE
RiluzoleRILUZOLEAscend Laboratories, LLCdd432c13-389e-46b3-8891-0cf1a58800ff2026-07-15Warnings, Adverse reactionsName fallback
brand name: Riluzole
generic name: RILUZOLE
RILUZOLERILUZOLEFlorida Pharmaceutical Products, LLCccead445-970c-46a1-9532-2848cc2aa3b62026-04-24Warnings, Adverse reactionsName fallback
brand name: RILUZOLE
generic name: RILUZOLE
RiluzoleRILUZOLEAvKAREb117b981-476c-f9b8-e053-2995a90aee5f2026-03-04Warnings, Adverse reactionsName fallback
brand name: Riluzole
generic name: RILUZOLE
TeglutikRILUZOLEEDW PHARMA1a3aeb59-d589-8d12-e063-6394a90a0a3a2025-12-31Name fallback
generic name: RILUZOLE
TeglutikRILUZOLEEDW PHARMA, INC0f2b5cfc-a23d-699a-e063-6394a90a67d12025-12-31Name fallback
generic name: RILUZOLE
TeglutikRILUZOLEEDW PHARMA125fdd37-02f7-a610-e063-6294a90a009d2025-12-31Name fallback
generic name: RILUZOLE
riluzoleRILUZOLEGlenmark Pharmaceuticals Inc., USAf1ce57e8-d3fe-422c-8724-3101c258898a2020-07-10Warnings, Adverse reactionsName fallback
brand name: riluzole
generic name: RILUZOLE
RiluzoleRILUZOLESun Pharmaceutical Industries, Inc.4c851be4-f0d0-4b24-baf9-427ddfc6f7b02020-05-16Warnings, Adverse reactionsName fallback
brand name: Riluzole
generic name: RILUZOLE

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-3285RILUZOLERILUZOLEApotex CorpANDACurrent
60505-3285RILUZOLERILUZOLEApotex CorpANDACurrent
60505-3285RILUZOLERILUZOLEApotex CorpANDACurrent
68084-908RILUZOLERILUZOLEAmerican Health PackagingANDACurrent
68084-908RILUZOLERILUZOLEAmerican Health PackagingANDACurrent
68084-908RILUZOLERILUZOLEAmerican Health PackagingANDACurrent