Home Applications 214955 Application 214955
Type ANDA
Sponsor AACE PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BUTALBITAL AND ACETAMINOPHEN ACETAMINOPHEN; BUTALBITAL TABLET;ORAL 50MG;300MG 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 A214955-001 BUTALBITAL AND ACETAMINOPHEN ACETAMINOPHEN; BUTALBITAL 300MG;50MG TABLET / ORAL AA 2022-08-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214955-001 AA
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.
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 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214955-001 BUTALBITAL AND ACETAMINOPHEN 50MG;300MG TABLET / ORAL AA 2022-08-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214955-001 BUTALBITAL AND ACETAMINOPHEN 50MG;300MG TABLET / ORAL AA 2022-08-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214955-001 BUTALBITAL AND ACETAMINOPHEN 50MG;300MG TABLET / ORAL AA 2022-08-16 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214955-001 BUTALBITAL AND ACETAMINOPHEN 300MG;50MG TABLET / ORAL AA 2022-08-16 a50c72e98297…
Observed Orange Book normalized TE history# 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 71406-109 BUTALBITAL AND ACETAMINOPHEN butalbital and acetaminophen AACE Pharmaceuticals, Inc. ANDA Current 71406-109 BUTALBITAL AND ACETAMINOPHEN butalbital and acetaminophen AACE Pharmaceuticals, Inc. ANDA Current 71406-109 BUTALBITAL AND ACETAMINOPHEN butalbital and acetaminophen AACE Pharmaceuticals, Inc. ANDA Current