FDA.reportPublic FDA data

Application 075782

Type
ANDA
Sponsor
VISTAPHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALPROIC ACIDVALPROIC ACIDSYRUP;ORAL250MG/5MLNoNo

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
A075782-001VALPROIC ACIDVALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075782-001AA

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 UTC2026-02A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A075782-001VALPROIC ACID250MG/5MLSYRUP / ORAL2000-12-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-223f01610625f2…
2019-09-15 20:21 UTC2019-09A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075782-001VALPROIC ACID250MG/5MLSYRUP / ORALAA2000-12-22cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075782-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075782-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075782-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075782-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075782-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075782-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075782-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075782-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075782-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075782-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075782-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075782-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075782-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075782-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075782-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075782-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075782-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075782-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075782-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075782-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075782-001AA187673890dc5c…
2020-12-22 03:56 UTC2020-12A075782-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075782-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075782-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A075782-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075782-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075782-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075782-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075782-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075782-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075782-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075782-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075782-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075782-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075782-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075782-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075782-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075782-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075782-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075782-001AA1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valproic AcidVALPROIC ACIDChartwell RX, LLC8051ad62-3b6e-461e-8090-60f5c0a904f42026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075782
application number: ANDA075782
ndc (product): 62135-196
Valproic AcidVALPROIC ACIDChartwell Governmental & Specialty RX, LLC.5d19f389-7180-4e01-845f-519b7ea60ba02025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075782
application number: ANDA075782

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62135-196Valproic AcidValproic AcidChartwell RX, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8787ORIG2000-12-22