FDA.reportPublic FDA data

Application 073590

Type
ANDA
Sponsor
ROXANE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LACTULOSELACTULOSESOLUTION;ORAL, RECTAL10GM/15MLNoNo

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
A073590-001LACTULOSELACTULOSE10GM/15MLSOLUTION / ORAL, RECTAL1992-05-29

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 UTC2022-10A073590-001LACTULOSE10GM/15MLSOLUTION / ORAL, RECTAL1992-05-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073590-001LACTULOSE10GM/15MLSOLUTION / ORAL, RECTAL1992-05-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A073590-001LACTULOSE10GM/15MLSOLUTION / ORAL, RECTAL1992-05-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A073590-001LACTULOSE10GM/15MLSOLUTION / ORAL, RECTAL1992-05-29a50c72e98297…

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 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LactuloseLACTULOSEAmerican Health Packaging8b79d0d6-b9e3-436e-bab7-01451b6f45cd2026-08-17Warnings, Adverse reactionsName fallback
brand name: Lactulose
generic name: LACTULOSE
LactuloseLACTULOSEAPOZEAL PHARMACEUTICALS INC72ac130a-de85-464d-9e9b-05cac0c54db12026-07-23Warnings, Adverse reactionsName fallback
brand name: Lactulose
generic name: LACTULOSE
LactuloseLACTULOSEPAI Holdings, LLC dba PAI Pharma5ae4b6da-44df-419a-9f2b-8c4d79f635c82026-07-07Warnings, Adverse reactionsName fallback
brand name: Lactulose
generic name: LACTULOSE
LACTULOSELACTULOSECardinal Health 107, LLC3cf3ff7c-67e7-42a9-8ebb-bd6c53937dd72026-05-19Warnings, Adverse reactionsName fallback
brand name: LACTULOSE
generic name: LACTULOSE
LactuloseLACTULOSEXttrium Laboratories, Inc.df62ad54-5aba-4d05-e053-2a95a90aa48d2026-04-14Warnings, Adverse reactionsName fallback
brand name: Lactulose
generic name: LACTULOSE
LactuloseLACTULOSEChartwell RX, LLCd6975cd8-80e0-43e2-809a-175ea7e407152026-01-28Warnings, Adverse reactionsName fallback
brand name: Lactulose
generic name: LACTULOSE
LactuloseLACTULOSEAPOZEAL PHARMACEUTICALS INCa8af7389-3699-4873-b05a-509af7e8eaab2026-01-06Warnings, Adverse reactionsName fallback
brand name: Lactulose
generic name: LACTULOSE
LactuloseLACTULOSEFoxland Pharmaceuticals, Inc.3363bdbd-f0d1-45b3-8193-7fdb0a310cc22025-12-16Warnings, Adverse reactionsName fallback
brand name: Lactulose
generic name: LACTULOSE
LactuloseLACTULOSEChartwell RX, LLC.bd9f1577-65e8-4521-b176-e5fc60a4a0182025-12-08Warnings, Adverse reactionsName fallback
brand name: Lactulose
generic name: LACTULOSE
LactuloseLACTULOSEChartwell Governmental & Specialty RX, LLC.887157ba-3c91-4fbf-bb12-b49c6fa4252c2025-11-13Warnings, Adverse reactionsName fallback
brand name: Lactulose
generic name: LACTULOSE
LACTULOSELACTULOSEAtlantic Biologicals Corp.3fb6e908-893c-5a57-e063-6294a90a1bfc2025-09-26Warnings, Adverse reactionsName fallback
brand name: LACTULOSE
generic name: LACTULOSE
LACTULOSELACTULOSEPAI Holdings, LLC dba PAI Pharma0f19e4ed-c90a-4330-a7fa-bf911aa98f092025-09-15Warnings, Adverse reactionsName fallback
brand name: LACTULOSE
generic name: LACTULOSE
LACTULOSELACTULOSEPAI Holdings, LLC dba PAI Pharmacbf0497c-9c8d-4dfa-bebd-64c5894684012025-09-15Warnings, Adverse reactionsName fallback
brand name: LACTULOSE
generic name: LACTULOSE
LactuloseLACTULOSETrifluent Pharma, Inc.3eaf273a-b49d-2595-e063-6394a90a1cf62025-09-13Warnings, Adverse reactionsName fallback
brand name: Lactulose
generic name: LACTULOSE
LACTULOSE CrystallineLACTULOSECumberland Assured Products Inc.59e75426-42ae-4904-941f-009181101a8a2025-09-01Warnings, Adverse reactionsName fallback
generic name: LACTULOSE
LactuloseLACTULOSESun Pharmaceutical Industries, Inc.391cfd01-c1fa-41f9-abd7-d0abe9a276342025-08-04Warnings, Adverse reactionsName fallback
brand name: Lactulose
generic name: LACTULOSE
EnuloseLACTULOSEBryant Ranch Prepackfa3aae7c-6f98-4fbb-85dc-32affe9874d52024-12-18Warnings, Adverse reactionsName fallback
generic name: LACTULOSE
GenerlacLACTULOSEChartwell RX, LLC35207edd-a5fe-4369-a079-7a8b0d2f2e912024-07-16Warnings, Adverse reactionsName fallback
generic name: LACTULOSE
LACTULOSELACTULOSEProficient Rx LP6bbabdc6-f6a8-4f67-a448-e452d1928deb2024-06-01Warnings, Adverse reactionsName fallback
brand name: LACTULOSE
generic name: LACTULOSE
LactuloseLACTULOSEFresenius Kabi Austria GmbHa89835c9-8ce5-4627-8d7d-70ff175b2e072022-11-09Adverse reactionsName fallback
brand name: Lactulose
generic name: LACTULOSE

Reported adverse events (FAERS/openFDA)#

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