FDA.reportPublic FDA data

Application 008719

Type
NDA
Sponsor
VALEANT PHARM INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVO-DROMORANLEVORPHANOL TARTRATEINJECTABLE;INJECTION2MG/MLNoNo

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
N008719-001LEVO-DROMORANLEVORPHANOL TARTRATE2MG/MLINJECTABLE / INJECTION1991-12-19

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 UTC2022-10N008719-001LEVO-DROMORAN2MG/MLINJECTABLE / INJECTION1991-12-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N008719-001LEVO-DROMORAN2MG/MLINJECTABLE / INJECTION1991-12-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N008719-001LEVO-DROMORAN2MG/MLINJECTABLE / INJECTION1991-12-19cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N008719-001LEVO-DROMORAN2MG/MLINJECTABLE / INJECTION1991-12-19a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levorphanol TartrateLEVORPHANOL TARTRATESpecGx LLC759c7040-0be0-4d17-be97-e467e423eaa82026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVORPHANOL TARTRATE
Levorphanol TartrateLEVORPHANOL TARTRATEBryant Ranch Prepackd7587868-561c-4e04-b02c-36a4b653a7622026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVORPHANOL TARTRATE
Levorphanol TartrateLEVORPHANOL TARTRATESun Pharmaceutical Industries, Inc.438cf3ea-04fe-4626-9f0f-adcda76336512026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVORPHANOL TARTRATE
Levorphanol TartrateLEVORPHANOL TARTRATELannett Company, Inc.a50debe1-90b3-4931-9ec0-67e88dd21b042026-01-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVORPHANOL TARTRATE
LEVORPHANOL TARTRATELEVORPHANOL TARTRATEHikma Pharmaceuticals USA Inc.b2ab70e4-ca0c-4a73-9c98-974bf94e890c2025-11-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVORPHANOL TARTRATE
Levorphanol TartrateLEVORPHANOL TARTRATEBryant Ranch Prepackdeed8652-9b9d-48b4-8c3e-9fdd7c46237e2025-11-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVORPHANOL TARTRATE
Levorphanol TartrateLEVORPHANOL TARTRATEVirtus Pharmaceuticals, LLC6e7ca993-c8b9-4510-a2b0-5bcc678d25712025-07-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVORPHANOL TARTRATE
Levorphanol TartrateLEVORPHANOL TARTRATEACERTIS PHARMACEUTICALS, LLC113a713f-830b-481c-bfa6-d44e3ac27f802025-06-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVORPHANOL TARTRATE

Reported adverse events (FAERS/openFDA)#

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