Application 040684

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXTENDED PHENYTOIN SODIUMPHENYTOIN SODIUMCAPSULE;ORAL100MG EXTENDEDNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A040684-001EXTENDED PHENYTOIN SODIUMPHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040684-001AB

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-053f01610625f2…
2019-09-15 20:21 UTC2019-09A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040684-001EXTENDED PHENYTOIN SODIUM100MG EXTENDEDCAPSULE / ORALAB2006-09-05cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040684-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040684-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040684-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040684-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040684-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040684-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040684-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040684-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040684-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040684-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040684-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040684-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040684-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040684-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040684-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040684-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040684-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040684-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040684-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040684-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040684-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040684-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040684-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040684-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040684-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040684-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040684-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040684-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040684-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040684-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040684-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040684-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040684-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040684-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040684-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040684-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040684-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040684-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040684-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040684-001AB1cb3db0bc1861…

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
Phenytoin SodiumPHENYTOIN SODIUMA-S Medication Solutionsef4e97a7-cd18-47a9-a016-2eca5481a87e2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
ndc (product): 50090-3539
Phenytoin SodiumPHENYTOIN SODIUMREMEDYREPACK INC.e33ce05d-9c60-4ede-8b13-e8c41a3de25d2026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
ndc (product): 70518-0107
Phenytoin SodiumPHENYTOIN SODIUMCoupler LLC51b660c3-7d88-77b2-e063-6294a90a02862026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMGolden State Medical Supply, Inc.36262a4c-33f1-40a5-e063-6394a90ad36a2026-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMREMEDYREPACK INC.844a16db-17d5-44da-819d-54f3e19cfec22026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
ndc (product): 70518-2293
Phenytoin SodiumPHENYTOIN SODIUMSun Pharmaceutical Industries, Inc.601f7353-225d-4a5d-9810-3869c2c218742026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
ndc (product): 51672-4111
Phenytoin SodiumPHENYTOIN SODIUMAvPAK4c2542b8-ac54-e85d-e063-6294a90a759b2026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMProficient Rx LPf4353734-29b0-4027-824d-2fc97f778c672026-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMMajor Pharmaceuticals46d5c0d1-a97b-46d9-8cf4-9947806733372025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMAphena Pharma Solutions - Tennessee, LLC3bc82d23-3950-f181-e063-6394a90ad5652025-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMAphena Pharma Solutions - Tennessee, LLC29b8d0a2-a96e-46a5-e063-6394a90a71132024-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMBryant Ranch Prepack6b4c2885-eae0-4c88-ada3-62a699df1dbb2024-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
Phenytoin SodiumPHENYTOIN SODIUMA-S Medication Solutionsd4459837-da26-4c97-8587-32eb1f682d582024-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040684
application number: ANDA040684
ndc (product): 50090-5700

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 51 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8020Phenytoin SodiumPhenytoin SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
21695-167Phenytoin SodiumPhenytoin SodiumRebel Distributors CorpANDACurrent
50090-3499Phenytoin SodiumPhenytoin SodiumA-S Medication SolutionsANDACurrent
50090-3539Phenytoin SodiumPhenytoin SodiumA-S Medication SolutionsANDACurrent
50090-3539Phenytoin SodiumPhenytoin SodiumA-S Medication SolutionsANDACurrent
50090-5700Phenytoin SodiumPhenytoin SodiumA-S Medication SolutionsANDACurrent
50090-5700Phenytoin SodiumPhenytoin SodiumA-S Medication SolutionsANDACurrent
51672-4111Phenytoin SodiumPhenytoin SodiumTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4111Phenytoin SodiumPhenytoin SodiumTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4111Phenytoin SodiumPhenytoin SodiumTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4111Phenytoin SodiumPhenytoin SodiumTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
53002-2501Phenytoin SodiumPhenytoin SodiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-4501Phenytoin SodiumPhenytoin SodiumRPK Pharmaceuticals, Inc.ANDACurrent
57664-808Phenytoin SodiumPhenytoin SodiumSun Pharmaceutical Industries, Inc.ANDACurrent
57664-808Phenytoin SodiumPhenytoin SodiumSun Pharmaceutical Industries, Inc.ANDACurrent
57664-808Phenytoin SodiumPhenytoin SodiumSun Pharmaceutical Industries, Inc.ANDACurrent
57664-808Phenytoin SodiumPhenytoin SodiumSun Pharmaceutical Industries, Inc.ANDACurrent
58118-4111Phenytoin SodiumPhenytoin SodiumClinical Solutions Wholesale, LLCANDACurrent
58118-4111Phenytoin SodiumPhenytoin SodiumClinical Solutions Wholesale, LLCANDACurrent
58118-4111Phenytoin SodiumPhenytoin SodiumClinical Solutions Wholesale, LLCANDACurrent
63629-2369Phenytoin SodiumPhenytoin SodiumBryant Ranch PrepackANDACurrent
63629-2369Phenytoin SodiumPhenytoin SodiumBryant Ranch PrepackANDACurrent
63629-2369Phenytoin SodiumPhenytoin SodiumBryant Ranch PrepackANDACurrent
63629-2369Phenytoin SodiumPhenytoin SodiumBryant Ranch PrepackANDACurrent
63629-8529Phenytoin SodiumPhenytoin SodiumBryant Ranch PrepackANDACurrent
63629-8529Phenytoin SodiumPhenytoin SodiumBryant Ranch PrepackANDACurrent
63629-8529Phenytoin SodiumPhenytoin SodiumBryant Ranch PrepackANDACurrent
63629-8529Phenytoin SodiumPhenytoin SodiumBryant Ranch PrepackANDACurrent
63629-8529Phenytoin SodiumPhenytoin SodiumBryant Ranch PrepackANDACurrent
64725-4111Phenytoin SodiumPhenytoin SodiumTYA PharmaceuticalsANDACurrent
67046-585Phenytoin SodiumPhenytoin SodiumContract Pharmacy Services-PAANDACurrent
70518-0107Phenytoin SodiumPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
70518-0107Phenytoin SodiumPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
70518-0107Phenytoin SodiumPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
70518-0107Phenytoin SodiumPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
70518-0107Phenytoin SodiumPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
70518-0107Phenytoin SodiumPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
70518-0107Phenytoin SodiumPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
70518-0107Phenytoin SodiumPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
70518-1776Phenytoin SodiumPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
70518-1776Phenytoin SodiumPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
70518-1776Phenytoin SodiumPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
70518-1776Phenytoin SodiumPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
70518-2293Phenytoin SodiumPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
70518-2293Phenytoin SodiumPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
70518-2293Phenytoin SodiumPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
70518-2293Phenytoin SodiumPhenytoin SodiumREMEDYREPACK INC.ANDACurrent
71335-0913Phenytoin SodiumPhenytoin SodiumBryant Ranch PrepackANDACurrent
71335-0913Phenytoin SodiumPhenytoin SodiumBryant Ranch PrepackANDACurrent
71335-0913Phenytoin SodiumPhenytoin SodiumBryant Ranch PrepackANDACurrent
71335-0913Phenytoin SodiumPhenytoin SodiumBryant Ranch PrepackANDACurrent