Home Applications 089405 Application 089405
Type ANDA
Sponsor MALLINCKRODT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TENCON ACETAMINOPHEN; BUTALBITAL CAPSULE;ORAL 650MG;50MG No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A089405-001 TENCON ACETAMINOPHEN; BUTALBITAL 650MG;50MG CAPSULE / ORAL 1990-05-15
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A089405-001 TENCON 650MG;50MG CAPSULE / ORAL 1990-05-15 cb3db0bc1861…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tencon BUTALBITAL AND ACETAMINOPHEN El Dorado Distributors LLC 4e4a9925-67aa-4be7-8bb7-c8b058ffe223 2024-05-15 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Tencon