Application 075882

Type
ANDA
Sponsor
ANI PHARMS INC

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 1.

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
A075882-001FLECAINIDE ACETATEFLECAINIDE ACETATE50MGTABLET / ORALAB2002-10-28
A075882-002FLECAINIDE ACETATEFLECAINIDE ACETATE100MGTABLET / ORALAB2002-10-28
A075882-003FLECAINIDE ACETATEFLECAINIDE ACETATE150MGTABLET / ORALAB2002-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075882-001AB
A075882-002AB
A075882-003AB

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075882-001FLECAINIDE ACETATE50MGTABLET / ORALAB2002-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075882-002FLECAINIDE ACETATE100MGTABLET / ORALAB2002-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075882-003FLECAINIDE ACETATE150MGTABLET / ORALAB2002-10-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075882-001FLECAINIDE ACETATE50MGTABLET / ORALAB2002-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075882-002FLECAINIDE ACETATE100MGTABLET / ORALAB2002-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075882-003FLECAINIDE ACETATE150MGTABLET / ORALAB2002-10-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075882-001FLECAINIDE ACETATE50MGTABLET / ORALAB2002-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075882-002FLECAINIDE ACETATE100MGTABLET / ORALAB2002-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075882-003FLECAINIDE ACETATE150MGTABLET / ORALAB2002-10-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075882-001FLECAINIDE ACETATE50MGTABLET / ORALAB2002-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075882-002FLECAINIDE ACETATE100MGTABLET / ORALAB2002-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075882-003FLECAINIDE ACETATE150MGTABLET / ORALAB2002-10-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075882-001FLECAINIDE ACETATE50MGTABLET / ORALAB2002-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075882-002FLECAINIDE ACETATE100MGTABLET / ORALAB2002-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075882-003FLECAINIDE ACETATE150MGTABLET / ORALAB2002-10-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075882-001FLECAINIDE ACETATE50MGTABLET / ORALAB2002-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075882-002FLECAINIDE ACETATE100MGTABLET / ORALAB2002-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075882-003FLECAINIDE ACETATE150MGTABLET / ORALAB2002-10-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075882-001FLECAINIDE ACETATE50MGTABLET / ORALAB2002-10-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075882-002FLECAINIDE ACETATE100MGTABLET / ORALAB2002-10-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075882-003FLECAINIDE ACETATE150MGTABLET / ORALAB2002-10-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075882-001FLECAINIDE ACETATE50MGTABLET / ORALAB2002-10-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075882-002FLECAINIDE ACETATE100MGTABLET / ORALAB2002-10-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075882-003FLECAINIDE ACETATE150MGTABLET / ORALAB2002-10-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075882-001FLECAINIDE ACETATE50MGTABLET / ORALAB2002-10-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075882-002FLECAINIDE ACETATE100MGTABLET / ORALAB2002-10-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075882-003FLECAINIDE ACETATE150MGTABLET / ORALAB2002-10-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075882-001FLECAINIDE ACETATE50MGTABLET / ORALAB2002-10-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A075882-002FLECAINIDE ACETATE100MGTABLET / ORALAB2002-10-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A075882-003FLECAINIDE ACETATE150MGTABLET / ORALAB2002-10-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075882-001FLECAINIDE ACETATE50MGTABLET / ORALAB2002-10-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075882-002FLECAINIDE ACETATE100MGTABLET / ORALAB2002-10-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075882-003FLECAINIDE ACETATE150MGTABLET / ORALAB2002-10-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075882-001FLECAINIDE ACETATE50MGTABLET / ORALAB2002-10-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075882-002FLECAINIDE ACETATE100MGTABLET / ORALAB2002-10-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075882-003FLECAINIDE ACETATE150MGTABLET / ORALAB2002-10-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075882-001FLECAINIDE ACETATE50MGTABLET / ORALAB2002-10-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075882-002FLECAINIDE ACETATE100MGTABLET / ORALAB2002-10-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075882-003FLECAINIDE ACETATE150MGTABLET / ORALAB2002-10-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075882-001FLECAINIDE ACETATE50MGTABLET / ORALAB2002-10-288072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075882-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075882-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075882-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075882-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075882-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075882-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075882-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075882-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075882-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075882-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075882-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075882-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075882-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075882-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075882-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075882-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075882-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075882-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075882-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075882-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075882-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075882-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075882-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075882-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075882-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075882-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075882-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075882-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075882-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075882-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075882-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075882-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075882-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075882-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075882-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075882-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075882-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075882-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075882-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075882-001AB18072bd15b7f6…

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 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flecainide AcetateFLECAINIDE ACETATEA-S Medication Solutions1a2a5e08-2697-4a00-94fe-de07148acbd92025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075882
application number: ANDA075882
ndc (product): 50090-2968
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepackbc304b04-9373-4e47-905d-6b3367ad3be72025-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075882
application number: ANDA075882
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepackd34fae51-3658-4456-b3ea-1217f0f522602025-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075882
application number: ANDA075882
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepackcf143926-439b-4005-be0e-1e049b44c0442025-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075882
application number: ANDA075882
Flecainide AcetateFLECAINIDE ACETATEBryant Ranch Prepackf0416c8c-faae-4e31-aa50-1fb7df10abf02025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075882
application number: ANDA075882
ndc (product): 71335-1487
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepack9929c166-8ba3-4159-a5f9-4618d5d227b02025-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075882
application number: ANDA075882
ndc (product): 63629-9184
Flecainide AcetateFLECAINIDE ACETATE TABLETGolden State Medical Supply, Inc.74355cd2-b50e-0dc2-e053-2a91aa0aa1642025-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075882
application number: ANDA075882
ndc (product): 51407-020
ndc (product): 51407-019
ndc (product): 51407-018
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepack8dc86db1-2a09-4625-80eb-ff6ce9de2d7a2025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075882
application number: ANDA075882
ndc (product): 63629-1945
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepack2028149f-6fc0-455c-bac5-729eeaa4aee52025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075882
application number: ANDA075882
ndc (product): 63629-1981
Flecainide AcetateFLECAINIDE ACETATE TABLETANI Pharmaceuticals, Inc.5a12889a-52ce-4dc4-9240-22d126f071ac2025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075882
application number: ANDA075882
ndc (product): 62559-381
ndc (product): 62559-380
ndc (product): 62559-382
Flecainide AcetateFLECAINIDE ACETATE TABLETProficient Rx LPee590951-cce8-4a1e-b3bd-ae0b610ebda92024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075882
application number: ANDA075882
Flecainide AcetateFLECAINIDE ACETATEA-S Medication Solutions179e3821-0342-4b84-96bb-3fcab213d74f2023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075882
application number: ANDA075882
ndc (product): 50090-6035
Flecainide AcetateFLECAINIDE ACETATE TABLETBryant Ranch Prepack5dc5b522-f16f-4b3b-b325-f4ace495f9662023-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075882
application number: ANDA075882
ndc (product): 63629-1946

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-0231Flecainide AcetateFlecainide Acetate TabletKAISER FOUNDATION HOSPITALSANDACurrent
50090-2968Flecainide AcetateFlecainide AcetateA-S Medication SolutionsANDACurrent
50090-2968Flecainide AcetateFlecainide AcetateA-S Medication SolutionsANDACurrent
50090-6035Flecainide AcetateFlecainide AcetateA-S Medication SolutionsANDACurrent
51407-018Flecainide AcetateFlecainide Acetate TabletGolden State Medical Supply Inc.ANDACurrent
51407-018Flecainide AcetateFlecainide Acetate TabletGolden State Medical Supply, Inc.ANDACurrent
51407-018Flecainide AcetateFlecainide Acetate TabletGolden State Medical SupplyANDACurrent
51407-018Flecainide AcetateFlecainide Acetate TabletGolden State Medical SupplyANDACurrent
51407-018Flecainide AcetateFlecainide Acetate TabletGolden State Medical Supply, Inc.ANDACurrent
51407-019Flecainide AcetateFlecainide Acetate TabletGolden State Medical Supply Inc.ANDACurrent
51407-019Flecainide AcetateFlecainide Acetate TabletGolden State Medical Supply, Inc.ANDACurrent
51407-019Flecainide AcetateFlecainide Acetate TabletGolden State Medical SupplyANDACurrent
51407-019Flecainide AcetateFlecainide Acetate TabletGolden State Medical SupplyANDACurrent
51407-019Flecainide AcetateFlecainide Acetate TabletGolden State Medical Supply, Inc.ANDACurrent
51407-020Flecainide AcetateFlecainide Acetate TabletGolden State Medical Supply Inc.ANDACurrent
51407-020Flecainide AcetateFlecainide Acetate TabletGolden State Medical Supply, Inc.ANDACurrent
51407-020Flecainide AcetateFlecainide Acetate TabletGolden State Medical SupplyANDACurrent
51407-020Flecainide AcetateFlecainide Acetate TabletGolden State Medical SupplyANDACurrent
51407-020Flecainide AcetateFlecainide Acetate TabletGolden State Medical Supply, Inc.ANDACurrent
62559-380Flecainide AcetateFlecainide Acetate TabletANI Pharmaceuticals, Inc.ANDACurrent
62559-380Flecainide AcetateFlecainide Acetate TabletANI Pharmaceuticals, Inc.ANDACurrent
62559-380Flecainide AcetateFlecainide Acetate TabletANI Pharmaceuticals, Inc.ANDACurrent
62559-381Flecainide AcetateFlecainide Acetate TabletANI Pharmaceuticals, Inc.ANDACurrent
62559-381Flecainide AcetateFlecainide Acetate TabletANI Pharmaceuticals, Inc.ANDACurrent
62559-381Flecainide AcetateFlecainide Acetate TabletANI Pharmaceuticals, Inc.ANDACurrent
62559-382Flecainide AcetateFlecainide Acetate TabletANI Pharmaceuticals, Inc.ANDACurrent
62559-382Flecainide AcetateFlecainide Acetate TabletANI Pharmaceuticals, Inc.ANDACurrent
62559-382Flecainide AcetateFlecainide Acetate TabletANI Pharmaceuticals, Inc.ANDACurrent
63629-1945Flecainide AcetateFlecainide Acetate TabletBryant Ranch PrepackANDACurrent
63629-1945Flecainide AcetateFlecainide Acetate TabletBryant Ranch PrepackANDACurrent
63629-1946Flecainide AcetateFlecainide Acetate TabletBryant Ranch PrepackANDACurrent
63629-1946Flecainide AcetateFlecainide Acetate TabletBryant Ranch PrepackANDACurrent
63629-1981Flecainide AcetateFlecainide Acetate TabletBryant Ranch PrepackANDACurrent
63629-1981Flecainide AcetateFlecainide Acetate TabletBryant Ranch PrepackANDACurrent
63629-9184Flecainide AcetateFlecainide Acetate TabletBryant Ranch PrepackANDACurrent
71335-1487Flecainide AcetateFlecainide AcetateBryant Ranch PrepackANDACurrent
71335-1487Flecainide AcetateFlecainide AcetateBryant Ranch PrepackANDACurrent