Application 203730

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIVALPROEX SODIUMDIVALPROEX SODIUMTABLET, EXTENDED RELEASE;ORALEQ 250MG VALPROIC ACIDNoNo
002DIVALPROEX SODIUMDIVALPROEX SODIUMTABLET, EXTENDED RELEASE;ORALEQ 500MG VALPROIC ACIDNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203730-001DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-29
A203730-002DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALABRS2015-05-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203730-001AB
A203730-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALABRS2015-05-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALABRS2015-05-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALABRS2015-05-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALABRS2015-05-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALABRS2015-05-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALABRS2015-05-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALABRS2015-05-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALABRS2015-05-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALABRS2015-05-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALABRS2015-05-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALABRS2015-05-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALABRS2015-05-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALABRS2015-05-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALABRS2015-05-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALABRS2015-05-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203730-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203730-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2015-05-29bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203730-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203730-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203730-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203730-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203730-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203730-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203730-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203730-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203730-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203730-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203730-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203730-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203730-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203730-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203730-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203730-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203730-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203730-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203730-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203730-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203730-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203730-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203730-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203730-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203730-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203730-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203730-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203730-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203730-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203730-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203730-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203730-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203730-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203730-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203730-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203730-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203730-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203730-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203730-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203730-002AB1bb7c543d1eb4…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.33f07aac-4dc5-4f97-976a-a84f93497bc62026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203730
application number: ANDA203730
ndc (product): 70518-2036
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.3b41cd15-9981-4d44-9c4b-e84168d864532026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203730
application number: ANDA203730
ndc (product): 70518-1556
Divalproex SodiumDIVALPROEX SODIUMCardinal Health 107, LLC283af6d2-8ea2-4225-b2e7-a2057dbdb7932026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203730
application number: ANDA203730
Divalproex SodiumDIVALPROEX SODIUMAmneal Pharmaceuticals LLC7d3352ee-a240-43ff-a243-29ad2bc989c72026-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203730
application number: ANDA203730
ndc (product): 65162-755
ndc (product): 65162-757
Divalproex SodiumDIVALPROEX SODIUMMajor Pharmaceuticalsef472176-7f98-4f88-be5e-a101fecb46fd2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203730
application number: ANDA203730
ndc (product): 0904-7181
ndc (product): 0904-7182
Divalproex SodiumDIVALPROEX SODIUMAvPAKe8cc336b-5191-7f8b-e053-2a95a90a6acb2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203730
application number: ANDA203730
ndc (product): 50268-259
ndc (product): 50268-260

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7181Divalproex SodiumDivalproex SodiumMajor PharmaceuticalsANDACurrent
0904-7181Divalproex SodiumDivalproex SodiumMajor PharmaceuticalsANDACurrent
0904-7182Divalproex SodiumDivalproex SodiumMajor PharmaceuticalsANDACurrent
0904-7182Divalproex SodiumDivalproex SodiumMajor PharmaceuticalsANDACurrent
50268-259Divalproex SodiumDivalproex SodiumAvPAKANDACurrent
50268-260Divalproex SodiumDivalproex SodiumAvPAKANDACurrent
65162-755Divalproex SodiumDivalproex SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-755Divalproex SodiumDivalproex SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-755Divalproex SodiumDivalproex SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-755Divalproex SodiumDivalproex SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-757Divalproex SodiumDivalproex SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-757Divalproex SodiumDivalproex SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-757Divalproex SodiumDivalproex SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-757Divalproex SodiumDivalproex SodiumAmneal Pharmaceuticals LLCANDACurrent
67046-150Divalproex SodiumDivalproex SodiumContract Pharmacy Services-PAANDACurrent
67296-1677Divalproex SodiumDivalproex SodiumRedPharm Drug, Inc.ANDACurrent
67296-1677Divalproex SodiumDivalproex SodiumRedPharm Drug, Inc.ANDACurrent
68788-7295Divalproex SodiumDivalproex SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7295Divalproex SodiumDivalproex SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7295Divalproex SodiumDivalproex SodiumPreferred Pharmaceuticals Inc.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2036Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2036Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2036Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2036Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2510Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2510Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2510Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2510Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2510Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
71610-311Divalproex SodiumDivalproex SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32463ORIG2015-06-03