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 3 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MESALAMINEMESALAMINEBryant Ranch Prepack063ca661-1b5c-4941-a5b9-5dd0fa46b3d02024-05-29Warnings, Adverse reactionsName fallback
brand name: MESALAMINE
generic name: MESALAMINE
MesalamineMESALAMINEAmneal Pharmaceuticals LLC00f77203-3615-47e8-ae25-6e1cf8a2a00a2024-05-23Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEBryant Ranch Prepackc9b1ef9d-1d06-48e7-87d2-7985b99124a62024-05-01Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
mesalamineMESALAMINEGolden State Medical Supply, Inc.170657d1-1f32-f036-e063-6294a90a4ed42024-04-26Warnings, Adverse reactionsName fallback
brand name: mesalamine
generic name: MESALAMINE
MESALAMINEMESALAMINELannett Company Inc.29dbe417-15a9-4c4d-846b-81cabda7ac702024-02-29Warnings, Adverse reactionsName fallback
brand name: MESALAMINE
generic name: MESALAMINE
MesalamineMESALAMINECamber Pharmaceuticals, Inc.efa9d039-ae1f-4cd6-98f2-e87a901dfaeb2024-02-26Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINECamber Pharmaceuticals, Inc.04ce2182-2e8c-4598-a269-550cfaddde6c2024-02-15Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEANI Pharmaceuticals, Inc.3cf751f2-a0c9-45d7-8acb-2bc61db0e4ac2024-02-14Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEAurobindo Pharma Limitedd6c0fc76-644e-4301-9672-f432061e3d372024-01-20Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MESALAMINEMESALAMINEAlembic Pharmaceuticals Inc.87d3d62d-2dc3-4e6f-be33-cabbca12e8f72024-01-09Warnings, Adverse reactionsName fallback
brand name: MESALAMINE
generic name: MESALAMINE
mesalamineMESALAMINETeva Pharmaceuticals USA, Inc.8d27a608-3ba1-4799-be38-c00fb08ce3ce2023-12-19Warnings, Adverse reactionsName fallback
brand name: mesalamine
generic name: MESALAMINE
Mesalamine RectalMESALAMINEAmring Pharmaceuticals Inc.87de237c-febb-42ca-b2a4-b444396f86402023-12-15Warnings, Adverse reactionsName fallback
generic name: MESALAMINE
MesalamineMESALAMINESun Pharmaceutical Industries, Inc.fd8b02de-7dfa-444d-a1f8-1436b578e0cb2023-12-01Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEMylan Pharmaceuticals Inc.c8b93ea3-0367-4605-b87f-06c3812ff3b72023-11-30Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
MesalamineMESALAMINEZydus Pharmaceuticals USA Inc.cd8493f7-91fd-4c2d-b3d7-c1301825586b2023-10-26Warnings, Adverse reactionsName fallback
brand name: Mesalamine
generic name: MESALAMINE
mesalamineMESALAMINEZydus Pharmaceuticals USA Inc.533bfaf5-0add-4b49-a4f2-ddea2b83f65d2023-10-26Warnings, Adverse reactionsName fallback
brand name: mesalamine
generic name: MESALAMINE
MESALAMINEMESALAMINEAlembic Pharmaceuticals Limited4ef59b85-e5a5-479f-a1fe-e1cee4d876702022-11-07Warnings, 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.