Application 088058

Type
ANDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VICODINACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL500MG;5MGNoNo

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
A088058-001VICODINACETAMINOPHEN; HYDROCODONE BITARTRATE500MG;5MGTABLET / ORAL1983-01-07

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 UTC2026-02A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-073f01610625f2…
2019-09-15 20:21 UTC2019-09A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088058-001VICODIN500MG;5MGTABLET / ORAL1983-01-07cb3db0bc1861…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18519SUPPL2006-12-27
43216SUPPL2005-07-22
43215SUPPL2005-07-22
43214SUPPL2005-07-22
43213SUPPL2005-07-22
43212SUPPL2005-07-22
43211SUPPL2005-07-22
43210SUPPL2005-07-22
43209SUPPL2005-07-22
43208SUPPL2005-07-22
43207SUPPL2005-07-22
22689SUPPL2005-07-22
22688SUPPL2005-07-22
22687SUPPL2005-07-22
22686SUPPL2005-07-22
22685SUPPL2005-07-22
22684SUPPL2005-07-22
22683SUPPL2005-07-22
22682SUPPL2005-07-22
22681SUPPL2005-07-22
22680SUPPL2005-07-22