FDA.reportPublic FDA data

Application 218093

Type
ANDA
Sponsor
OMSAV PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLECAINIDE ACETATEFLECAINIDE ACETATETABLET;ORAL50MGNoNo
002FLECAINIDE ACETATEFLECAINIDE ACETATETABLET;ORAL100MGNoNo
003FLECAINIDE ACETATEFLECAINIDE ACETATETABLET;ORAL150MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218093-001FLECAINIDE ACETATEFLECAINIDE ACETATE50MGTABLET / ORALAB2026-04-22
A218093-002FLECAINIDE ACETATEFLECAINIDE ACETATE100MGTABLET / ORALAB2026-04-22
A218093-003FLECAINIDE ACETATEFLECAINIDE ACETATE150MGTABLET / ORALAB2026-04-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A218093-001AB
A218093-002AB
A218093-003AB

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
2026-09-14 22:38:342026-08A218093-001FLECAINIDE ACETATE50MGTABLET / ORALAB2026-04-2284e616aacf4f…
2026-09-14 22:38:342026-08A218093-002FLECAINIDE ACETATE100MGTABLET / ORALAB2026-04-2284e616aacf4f…
2026-09-14 22:38:342026-08A218093-003FLECAINIDE ACETATE150MGTABLET / ORALAB2026-04-2284e616aacf4f…
2026-08-18 06:07:402026-07A218093-001FLECAINIDE ACETATE50MGTABLET / ORALAB2026-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A218093-002FLECAINIDE ACETATE100MGTABLET / ORALAB2026-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A218093-003FLECAINIDE ACETATE150MGTABLET / ORALAB2026-04-22caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218093-001FLECAINIDE ACETATE50MGTABLET / ORALAB2026-04-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218093-002FLECAINIDE ACETATE100MGTABLET / ORALAB2026-04-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218093-003FLECAINIDE ACETATE150MGTABLET / ORALAB2026-04-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218093-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A218093-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A218093-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A218093-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218093-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218093-003AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218093-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218093-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218093-003AB1a50c72e98297…

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 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepack2028149f-6fc0-455c-bac5-729eeaa4aee52025-08-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
Flecainide AcetateFLECAINIDE ACETATE TABLETANI Pharmaceuticals, Inc.5a12889a-52ce-4dc4-9240-22d126f071ac2025-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepackbf810a3b-1a71-4a05-bf54-d5a6caba444b2025-06-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEHikma Pharmaceuticals USA Inc.4f6b78d4-8ac8-464b-bb78-ee70cbc978982024-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEA-S Medication Solutions475a52a9-f18c-4a69-91f0-8f5e601f43362024-11-13Boxed warning, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEChartwell RX, LLCa604aee4-30d5-4007-9882-98137d0d867f2024-10-28Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEAmneal Pharmaceuticals LLCd462d58e-fc3c-4c92-a210-e135eb1f4b772024-10-25Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATE TABLETProficient Rx LPee590951-cce8-4a1e-b3bd-ae0b610ebda92024-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepack6b73e32f-851b-4503-8296-e5db3a584b752024-05-24Boxed warning, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepack2013e6ef-9141-42c3-8ea8-285840ecdd152024-04-03Boxed warning, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepack5d6a4772-663e-468d-a8e1-4085e1b32bf72024-04-03Boxed warning, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEAurobindo Pharma Limited14e89448-3a18-42e3-8537-2589be1ef94e2024-01-09Boxed warning, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATERising Pharma Holdings, Inc.e56335c1-5508-4136-bd2e-18385623e4972024-01-09Boxed warning, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATEA-S Medication Solutions179e3821-0342-4b84-96bb-3fcab213d74f2023-11-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate
generic name: FLECAINIDE ACETATE
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepack5dc5b522-f16f-4b3b-b325-f4ace495f9662023-11-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Flecainide Acetate

Reported adverse events (FAERS/openFDA)#

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