FDA.reportPublic FDA data

Application 220016

Type
ANDA
Sponsor
KLM LABS PVT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MESALAMINEMESALAMINEENEMA;RECTAL4GM/60MLNoNo

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
A220016-001MESALAMINEMESALAMINE4GM/60MLENEMA / RECTALAB2026-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A220016-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A220016-001MESALAMINE4GM/60MLENEMA / RECTALAB2026-03-31c2088c7a36db…
2026-09-14 22:38:342026-08A220016-001MESALAMINE4GM/60MLENEMA / RECTALAB2026-03-3184e616aacf4f…
2026-08-18 06:07:402026-07A220016-001MESALAMINE4GM/60MLENEMA / RECTALAB2026-03-31caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220016-001MESALAMINE4GM/60MLENEMA / RECTALAB2026-03-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A220016-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08A220016-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A220016-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220016-001AB1a50c72e98297…

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 2 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MesalamineMESALAMINETakeda Pharmaceuticals America, Inc.4e3b6325-a5bf-4c47-931c-142c0e4d7c3a2025-01-09Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEAvPAKf2657911-6f06-71fb-e053-2a95a90ae6f72025-01-09Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEZydus Lifesciences Limitedaa63b4bb-2de7-40aa-b26b-1b00b0183eac2025-01-09Name fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEZydus Pharmaceuticals USA Inc.f458d574-7b5b-44f1-86be-8b18880dc67f2025-01-08Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
mesalamineMESALAMINEZydus Lifesciences Limited29c0dd58-d2cf-40fa-bc32-0eab619373312024-11-30Name fallback
brand name: mesalamine
generic name: MESALAMINE
mesalamineMESALAMINEZydus Lifesciences Limited52d96501-47f3-45d8-a181-98763b9f89652024-11-30Name fallback
brand name: mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEZydus Lifesciences Limited04073681-a834-4f45-91c5-224b608b30e62024-11-30Name fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEAmerican Health Packaging77140634-9f32-40ca-8c83-9fcc3e373c162024-11-22Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINENorthStar RxLLC8233f158-9da5-4fd2-b2c3-9db89448371f2024-11-21Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEAmerican Health Packaginga74ab9f4-ffcd-4bbf-88a5-342e6a38aabb2024-11-21Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEBryant Ranch Prepack1e561474-6169-410e-b83d-7e96d375831d2024-11-07Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEBryant Ranch Prepack9756d07b-2939-460f-94d3-e338c28cb9932024-11-07Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEBryant Ranch Prepackb48df65a-a717-479e-9122-8b0f1406c8412024-11-01Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINESun Pharmaceutical Industries Inc.c2f84490-70b8-4998-907d-a77e9f791de12024-08-27Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEBryant Ranch Prepackbaa76dde-3c5b-4ff4-ba0c-f19660a796c12024-08-14Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEPadagis Israel Pharmaceuticals Ltdb2a5b110-7537-4ffc-bf0a-f0fe13379c9d2024-08-01Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEPadagis Israel Pharmaceuticals Ltdd50f2c37-5675-49f3-bdd4-3b16d333ed402024-08-01Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEPadagis Israel Pharmaceuticals Ltda4ddf68d-1502-4242-89aa-c96436bdcbf62024-08-01Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEBryant Ranch Prepack06792d20-d7e9-4b66-a4cb-cd0cf1a2db252024-06-28Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINERising Pharma Holdings, Inc.de981df1-747a-480d-a866-e72332a1544d2024-06-14Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE

Reported adverse events (FAERS/openFDA)#

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