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 1 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RowasaMESALAMINEViatris Specialty LLCe505ab99-1943-4216-a178-4d5dbe64e3b22026-08-03Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
mesalamineMESALAMINEMajor Pharmaceuticals14ac4435-903b-41f5-a3c4-8c73de3e4cef2026-07-27Warnings, Adverse reactionsName fallback
brand name: mesalamine
generic name: MESALAMINE
mesalamineMESALAMINEZydus Pharmaceuticals USA Inc.ad8c7930-92e2-4372-a874-da22b9ae333e2026-07-14Warnings, Adverse reactionsName fallback
brand name: mesalamine
generic name: MESALAMINE
MesalamineMESALAMINESandoz Inc47b5d1ee-b439-4ccb-9b01-c0875ccd748a2026-06-30Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINENuvaila Limited875d573f-99a1-426a-8321-4d511690d5032026-06-03Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEANI Pharmaceuticals, Inc.485ed763-976e-4410-a401-7ff762a931b32026-05-20Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
LialdaMESALAMINETakeda Pharmaceuticals America, Inc.3098a080-be86-4265-9818-7fc4beab77b72026-03-24Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MesalamineMESALAMINEGolden State Medical Supply, Inc.4c4ffb68-3ca4-35cd-e063-6294a90ab9292026-03-05Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEActavis Pharma, Inc.73317da3-cba0-4106-9e88-79b0e2f642af2026-02-24Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEAvKARE22f3ee49-ac57-84f5-e063-6394a90aae912026-01-14Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEChartwell RX, LLC9703f92d-1d15-4376-8b2b-51502c2660122025-12-17Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MESALAMINEMESALAMINECamber Pharmaceuticals, Inc.ef471372-8d9f-4d95-9371-44522c69058f2025-12-10Warnings, Adverse reactionsName fallback
brand name: MESALAMINE
generic name: MESALAMINE
MesalamineMESALAMINERising Pharma Holdings, Inc.c26ae6cb-041b-4cfc-90ca-c4e1cb23458c2025-12-10Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEIngenus Pharmaceuticals, LLC58503afe-b8d4-4710-a194-e3acd64ecf1f2025-12-05Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEUpsher-Smith Laboratories, LLC1e6978d0-01db-477d-a90f-27561777480f2025-12-01Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEEncube Ethicals, Inc.d6b68275-b2a4-4965-9862-cf14acf8c5992025-10-07Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEAmerican Health Packaginge638681d-8fca-4bf8-a1fb-8e52357a64da2025-05-21Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEActavis Pharma, Inc.ba1e3bd4-fbe0-46a5-961e-167ccb09672c2025-03-27Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
PentasaMESALAMINETakeda Pharmaceuticals America, Inc.e39d9a3d-5d3a-4bb6-aab1-fdbb2a5986062025-01-15Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MesalamineMESALAMINENorthstar Rx LLC.7ac78fa0-60a8-48dd-abc4-a487f98039a22025-01-10Warnings, 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.