Application 040301

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001WARFARIN SODIUMWARFARIN SODIUMTABLET;ORAL10MGNoNo
002WARFARIN SODIUMWARFARIN SODIUMTABLET;ORAL1MGNoNo
003WARFARIN SODIUMWARFARIN SODIUMTABLET;ORAL2MGNoNo
004WARFARIN SODIUMWARFARIN SODIUMTABLET;ORAL2.5MGNoNo
005WARFARIN SODIUMWARFARIN SODIUMTABLET;ORAL3MGNoNo
006WARFARIN SODIUMWARFARIN SODIUMTABLET;ORAL4MGNoNo
007WARFARIN SODIUMWARFARIN SODIUMTABLET;ORAL5MGNoNo
008WARFARIN SODIUMWARFARIN SODIUMTABLET;ORAL6MGNoNo
009WARFARIN SODIUMWARFARIN SODIUMTABLET;ORAL7.5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040301-001WARFARIN SODIUMWARFARIN SODIUM10MGTABLET / ORALAB1999-07-15
A040301-002WARFARIN SODIUMWARFARIN SODIUM1MGTABLET / ORALAB1999-07-15
A040301-003WARFARIN SODIUMWARFARIN SODIUM2MGTABLET / ORALAB1999-07-15
A040301-004WARFARIN SODIUMWARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-15
A040301-005WARFARIN SODIUMWARFARIN SODIUM3MGTABLET / ORALAB1999-07-15
A040301-006WARFARIN SODIUMWARFARIN SODIUM4MGTABLET / ORALAB1999-07-15
A040301-007WARFARIN SODIUMWARFARIN SODIUM5MGTABLET / ORALAB1999-07-15
A040301-008WARFARIN SODIUMWARFARIN SODIUM6MGTABLET / ORALAB1999-07-15
A040301-009WARFARIN SODIUMWARFARIN SODIUM7.5MGTABLET / ORALAB1999-07-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 9 matching rows.

Application-product, TE code table
Application-productTE code
A040301-001AB
A040301-002AB
A040301-003AB
A040301-004AB
A040301-005AB
A040301-006AB
A040301-007AB
A040301-008AB
A040301-009AB

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 10 · 378 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040301-001WARFARIN SODIUM10MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-002WARFARIN SODIUM1MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-003WARFARIN SODIUM2MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-004WARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-005WARFARIN SODIUM3MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-006WARFARIN SODIUM4MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-007WARFARIN SODIUM5MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-008WARFARIN SODIUM6MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-009WARFARIN SODIUM7.5MGTABLET / ORALAB1999-07-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040301-001WARFARIN SODIUM10MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-002WARFARIN SODIUM1MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-003WARFARIN SODIUM2MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-004WARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-005WARFARIN SODIUM3MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-006WARFARIN SODIUM4MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-007WARFARIN SODIUM5MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-008WARFARIN SODIUM6MGTABLET / ORALAB1999-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-009WARFARIN SODIUM7.5MGTABLET / ORALAB1999-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-001WARFARIN SODIUM10MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-002WARFARIN SODIUM1MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-003WARFARIN SODIUM2MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-004WARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-005WARFARIN SODIUM3MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-006WARFARIN SODIUM4MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-007WARFARIN SODIUM5MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-008WARFARIN SODIUM6MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-009WARFARIN SODIUM7.5MGTABLET / ORALAB1999-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040301-001WARFARIN SODIUM10MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-002WARFARIN SODIUM1MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-003WARFARIN SODIUM2MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-004WARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-005WARFARIN SODIUM3MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-006WARFARIN SODIUM4MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-007WARFARIN SODIUM5MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-008WARFARIN SODIUM6MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-009WARFARIN SODIUM7.5MGTABLET / ORALAB1999-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-001WARFARIN SODIUM10MGTABLET / ORALAB1999-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-002WARFARIN SODIUM1MGTABLET / ORALAB1999-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-003WARFARIN SODIUM2MGTABLET / ORALAB1999-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-004WARFARIN SODIUM2.5MGTABLET / ORALAB1999-07-15fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 10 · 378 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040301-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-008AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040301-009AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040301-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-008AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040301-009AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-008AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040301-009AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040301-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-008AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040301-009AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040301-004AB1fd3edfee7708…

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.bd6ea120-5d1c-4815-94f2-81e28dc6b7a92026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMA-S Medication Solutions8cd0e744-b499-4344-b1db-59f85950e1692026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMA-S Medication Solutions991b1e3e-236e-44cf-ad61-7233f777ce672026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.6b227c9e-02e9-4ec9-8b11-3ab6fe5093e52026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.72d3ea20-27e4-4368-a666-a9b76530dbb92026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.61ab23a7-bc67-4777-854a-bf43c788a69a2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.7b3b6f89-1feb-4939-a95b-7ad0707f4d762026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.73b8e5ab-86f8-44f8-b290-346acb81c9ae2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMCardinal Health 107, LLCcdbbc317-35d3-42ba-94f0-c838913585292025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
ndc (product): 55154-4695
ndc (product): 55154-4697
Warfarin SodiumWARFARIN SODIUMBryant Ranch Prepack694e258d-86bd-440c-870b-a7d27fb1c4672025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
ndc (product): 63629-4543
Warfarin SodiumWARFARIN SODIUMGolden State Medical Supply, Inc.ba8b4ead-d080-91e7-e053-2995a90a82fe2025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMSun Pharmaceutical Industries, Inc.8ad881e0-ca41-42ad-9d7d-eb85b3a30af02025-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
Warfarin SodiumWARFARIN SODIUMCardinal Health 107, LLC7c4deb97-9966-4c8e-9ba6-bb260b71e1302025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
ndc (product): 55154-4696
Warfarin SodiumWARFARIN SODIUMAmerican Health Packagingab047628-67d0-4a64-8d77-36b054969b442024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
ndc (product): 62584-984
ndc (product): 62584-994
Warfarin SodiumWARFARIN SODIUMAmerican Health Packagingfeaa5f6f-9753-4f37-ab81-04c9c6b45e6a2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
ndc (product): 68084-027
Warfarin SodiumWARFARIN SODIUMAphena Pharma Solutions - Tennessee, LLCe73d37f8-8a28-4d93-9529-fd1e2c84228a2021-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
ndc (product): 71610-589
ndc (product): 71610-593
Warfarin SodiumWARFARIN SODIUMAphena Pharma Solutions - Tennessee, LLC2c8f47c6-a180-4ad8-b962-04069d2270cb2021-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040301
application number: ANDA040301
ndc (product): 71610-574
ndc (product): 71610-575

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 109 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53808-0994Warfarin SodiumWARFARIN SODIUMState of Florida DOH Central PharmacyANDACurrent
53808-0997Warfarin SodiumWARFARIN SODIUMState of Florida DOH Central PharmacyANDACurrent
55154-4695Warfarin SodiumWarfarin SodiumCardinal HealthANDACurrent
55154-4695Warfarin SodiumWarfarin SodiumCardinal Health 107, LLCANDACurrent
55154-4696Warfarin SodiumWarfarin SodiumCardinal HealthANDACurrent
55154-4696Warfarin SodiumWarfarin SodiumCardinal Health 107, LLCANDACurrent
55154-4696Warfarin SodiumWarfarin SodiumCardinal HealthANDACurrent
55154-4697Warfarin SodiumWarfarin SodiumCardinal HealthANDACurrent
55154-4697Warfarin SodiumWarfarin SodiumCardinal Health 107, LLCANDACurrent
62584-984Warfarin SodiumWarfarin SodiumAmerican Health PackagingANDACurrent
62584-984Warfarin SodiumWarfarin SodiumAmerican Health PackagingANDACurrent
62584-984Warfarin SodiumWarfarin SodiumAmerican Health PackagingANDACurrent
62584-984Warfarin SodiumWarfarin SodiumAmerican Health PackagingANDACurrent
62584-994Warfarin SodiumWarfarin SodiumAmerican Health PackagingANDACurrent
62584-994Warfarin SodiumWarfarin SodiumAmerican Health PackagingANDACurrent
62584-994Warfarin SodiumWarfarin SodiumAmerican Health PackagingANDACurrent
62584-994Warfarin SodiumWarfarin SodiumAmerican Health PackagingANDACurrent
63629-2548Warfarin SodiumWarfarin SodiumBryant Ranch PrepackANDACurrent
63629-4543Warfarin SodiumWarfarin SodiumBryant Ranch PrepackANDACurrent
64205-032Warfarin SodiumWarfarin SodiumReadyMedsANDACurrent
67544-318Warfarin SodiumWarfarin SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
68084-027Warfarin SodiumWarfarin SodiumAmerican Health PackagingANDACurrent
68084-027Warfarin SodiumWarfarin SodiumAmerican Health PackagingANDACurrent
68084-027Warfarin SodiumWarfarin SodiumAmerican Health PackagingANDACurrent
68084-027Warfarin SodiumWarfarin SodiumAmerican Health PackagingANDACurrent
71610-574Warfarin SodiumWarfarin SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-575Warfarin SodiumWarfarin SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-589Warfarin SodiumWarfarin SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-593Warfarin SodiumWarfarin SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
38880ORIG2004-06-30
22122ORIG2003-07-23
7614ORIG1999-06-15