Application 090935

Type
ANDA
Sponsor
INVAGEN PHARMS

Application Products#

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

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
A090935-001WARFARIN SODIUMWARFARIN SODIUM1MGTABLET / ORALAB2011-05-25
A090935-002WARFARIN SODIUMWARFARIN SODIUM2MGTABLET / ORALAB2011-05-25
A090935-003WARFARIN SODIUMWARFARIN SODIUM2.5MGTABLET / ORALAB2011-05-25
A090935-004WARFARIN SODIUMWARFARIN SODIUM3MGTABLET / ORALAB2011-05-25
A090935-005WARFARIN SODIUMWARFARIN SODIUM4MGTABLET / ORALAB2011-05-25
A090935-006WARFARIN SODIUMWARFARIN SODIUM5MGTABLET / ORALAB2011-05-25
A090935-007WARFARIN SODIUMWARFARIN SODIUM6MGTABLET / ORALAB2011-05-25
A090935-008WARFARIN SODIUMWARFARIN SODIUM7.5MGTABLET / ORALAB2011-05-25
A090935-009WARFARIN SODIUMWARFARIN SODIUM10MGTABLET / ORALAB2011-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090935-001AB
A090935-002AB
A090935-003AB
A090935-004AB
A090935-005AB
A090935-006AB
A090935-007AB
A090935-008AB
A090935-009AB

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 06:07:402026-07A090935-001WARFARIN SODIUM1MGTABLET / ORALAB2011-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-002WARFARIN SODIUM2MGTABLET / ORALAB2011-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-003WARFARIN SODIUM2.5MGTABLET / ORALAB2011-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-004WARFARIN SODIUM3MGTABLET / ORALAB2011-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-005WARFARIN SODIUM4MGTABLET / ORALAB2011-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-006WARFARIN SODIUM5MGTABLET / ORALAB2011-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-007WARFARIN SODIUM6MGTABLET / ORALAB2011-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-008WARFARIN SODIUM7.5MGTABLET / ORALAB2011-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-009WARFARIN SODIUM10MGTABLET / ORALAB2011-05-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090935-001WARFARIN SODIUM1MGTABLET / ORALAB2011-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-002WARFARIN SODIUM2MGTABLET / ORALAB2011-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-003WARFARIN SODIUM2.5MGTABLET / ORALAB2011-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-004WARFARIN SODIUM3MGTABLET / ORALAB2011-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-005WARFARIN SODIUM4MGTABLET / ORALAB2011-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-006WARFARIN SODIUM5MGTABLET / ORALAB2011-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-007WARFARIN SODIUM6MGTABLET / ORALAB2011-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-008WARFARIN SODIUM7.5MGTABLET / ORALAB2011-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-009WARFARIN SODIUM10MGTABLET / ORALAB2011-05-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-001WARFARIN SODIUM1MGTABLET / ORALAB2011-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-002WARFARIN SODIUM2MGTABLET / ORALAB2011-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-003WARFARIN SODIUM2.5MGTABLET / ORALAB2011-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-004WARFARIN SODIUM3MGTABLET / ORALAB2011-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-005WARFARIN SODIUM4MGTABLET / ORALAB2011-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-006WARFARIN SODIUM5MGTABLET / ORALAB2011-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-007WARFARIN SODIUM6MGTABLET / ORALAB2011-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-008WARFARIN SODIUM7.5MGTABLET / ORALAB2011-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-009WARFARIN SODIUM10MGTABLET / ORALAB2011-05-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090935-001WARFARIN SODIUM1MGTABLET / ORALAB2011-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-002WARFARIN SODIUM2MGTABLET / ORALAB2011-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-003WARFARIN SODIUM2.5MGTABLET / ORALAB2011-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-004WARFARIN SODIUM3MGTABLET / ORALAB2011-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-005WARFARIN SODIUM4MGTABLET / ORALAB2011-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-006WARFARIN SODIUM5MGTABLET / ORALAB2011-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-007WARFARIN SODIUM6MGTABLET / ORALAB2011-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-008WARFARIN SODIUM7.5MGTABLET / ORALAB2011-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-009WARFARIN SODIUM10MGTABLET / ORALAB2011-05-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090935-001WARFARIN SODIUM1MGTABLET / ORALAB2011-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090935-002WARFARIN SODIUM2MGTABLET / ORALAB2011-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090935-003WARFARIN SODIUM2.5MGTABLET / ORALAB2011-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090935-004WARFARIN SODIUM3MGTABLET / ORALAB2011-05-25fd3edfee7708…

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 06:07:402026-07A090935-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-008AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090935-009AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090935-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-008AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090935-009AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-008AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090935-009AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090935-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-008AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090935-009AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090935-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090935-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090935-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090935-004AB1fd3edfee7708…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Warfarin SodiumWARFARINAphena Pharma Solutions - Tennessee, LLC4f276251-49b7-438f-9c47-f1cdfc47e5192026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090935
application number: ANDA090935
Warfarin SodiumWARFARINGolden State Medical Supply, Inc.a2f6c9f7-87dc-7428-e053-2995a90a1de62025-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090935
application number: ANDA090935
WARFARIN SODIUMWARFARIN SODIUMDIRECT RXc186d1ff-64dd-bfcb-e053-2a95a90af8002025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090935
application number: ANDA090935
ndc (product): 72189-210
Warfarin SodiumWARFARINAphena Pharma Solutions - Tennessee, LLC52b3c2f6-b5ca-44ae-bdcc-552d5191034f2021-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090935
application number: ANDA090935
ndc (product): 71610-462
Warfarin SodiumWARFARINAphena Pharma Solutions - Tennessee, LLCa98916a5-cdb2-4251-bdea-0245c763b2f12020-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090935
application number: ANDA090935
ndc (product): 71610-491
ndc (product): 71610-490
Warfarin SodiumWARFARINExelan Pharmaceuticals Inc.c0cc4511-e656-4b6d-96cd-e02e76173b9d2020-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090935
application number: ANDA090935
ndc (product): 76282-329
ndc (product): 76282-328
ndc (product): 76282-332
ndc (product): 76282-333
ndc (product): 76282-330
ndc (product): 76282-331
ndc (product): 76282-335
ndc (product): 76282-334
ndc (product): 76282-327
Warfarin SodiumWARFARINAphena Pharma Solutions - Tennessee, LLC91f24482-d4cb-4a09-a97e-64f6e49071ee2020-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090935
application number: ANDA090935
ndc (product): 71610-448

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 145 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68788-7357Warfarin Sodiumwarfarin sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7357Warfarin Sodiumwarfarin sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7357Warfarin Sodiumwarfarin sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7358Warfarin Sodiumwarfarin sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7358Warfarin Sodiumwarfarin sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7358Warfarin Sodiumwarfarin sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7358Warfarin Sodiumwarfarin sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7515Warfarin Sodiumwarfarin sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7515Warfarin Sodiumwarfarin sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7515Warfarin Sodiumwarfarin sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7515Warfarin Sodiumwarfarin sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2900Warfarin Sodiumwarfarin sodiumREMEDYREPACK INC.ANDACurrent
70518-2900Warfarin Sodiumwarfarin sodiumREMEDYREPACK INC.ANDACurrent
70934-585Warfarin Sodiumwarfarin sodiumDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-585Warfarin Sodiumwarfarin sodiumDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-586Warfarin Sodiumwarfarin sodiumDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-586Warfarin Sodiumwarfarin sodiumDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-587Warfarin SodiumWarfarinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-588Warfarin SodiumWarfarinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-589Warfarin SodiumWarfarinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-950Warfarin Sodiumwarfarin sodiumProficient Rx LPANDACurrent
71205-951Warfarin Sodiumwarfarin sodiumProficient Rx LPANDACurrent
71205-952Warfarin Sodiumwarfarin sodiumProficient Rx LPANDACurrent
71205-953Warfarin Sodiumwarfarin sodiumProficient Rx LPANDACurrent
71205-954Warfarin Sodiumwarfarin sodiumProficient Rx LPANDACurrent
71205-955Warfarin Sodiumwarfarin sodiumProficient Rx LPANDACurrent
71335-1718Warfarin Sodiumwarfarin sodiumBryant Ranch PrepackANDACurrent
71335-2148Warfarin Sodiumwarfarin sodiumBryant Ranch PrepackANDACurrent
71610-173Warfarin Sodiumwarfarin sodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-179Warfarin Sodiumwarfarin sodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-448Warfarin SodiumWarfarinAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-458Warfarin SodiumWarfarinAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-462Warfarin SodiumWarfarinAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-462Warfarin SodiumWarfarinAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-490Warfarin SodiumWarfarinAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-491Warfarin SodiumWarfarinAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-519Warfarin SodiumWarfarinAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-210WARFARIN SODIUMWARFARIN SODIUMDIRECT RXANDACurrent
76282-327Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-327Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-327Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-328Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-328Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-328Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-329Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-329Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-329Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-330Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-330Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-330Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-331Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-331Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-331Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-332Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-332Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-332Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-333Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-333Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-333Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-334Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-334Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-334Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-335Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-335Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent
76282-335Warfarin SodiumWarfarinExelan Pharmaceuticals Inc.ANDACurrent