Home Applications 072344 Application 072344
Type ANDA
Sponsor ACP NIMBLE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ACEPHEN ACETAMINOPHEN SUPPOSITORY;RECTAL 325MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A072344-001 ACEPHEN ACETAMINOPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27
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 · 43 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 2026-09-14 22:38:34 2026-08 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072344-001 ACEPHEN 325MG SUPPOSITORY / RECTAL 1992-03-27 f41ea6bd6efb…
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 47 of 48 · 956 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 8 hr Pain Relief ACETAMINOPHEN DOLGENCORP, INC. ea2ebb7b-ceab-567a-e053-2995a90aa402 2023-04-20 Warnings Name fallback generic name: ACETAMINOPHEN HEB ACETAMINOPHEN HEB 96b1808f-defa-28cb-e053-2995a90a563b 2023-04-12 Warnings Name fallback generic name: ACETAMINOPHEN Arthritis Pain Relief ACETAMINOPHEN WINCO FOODS, LLC f45f43da-b994-2bc8-e053-2995a90a93e0 2023-04-11 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Solupharm Pharmazeutische Erzeugnisse GmbH adeebc6c-c82f-40dc-b813-1b02244984ce 2023-02-13 Warnings, Adverse reactions Name fallback generic name: ACETAMINOPHEN Pain Relief 8 HR ACETAMINOPHEN H E B b5c7e93b-e626-49c3-a7d4-773475f945ae 2022-11-12 Warnings Name fallback generic name: ACETAMINOPHEN arthritis pain relief ACETAMINOPHEN Meijer Distribution Inc c388f3a5-03bb-4fed-b81a-bb876bc260f0 2022-10-27 Warnings Name fallback generic name: ACETAMINOPHEN Pain Relief ACETAMINOPHEN Meijer Distribution Inc bfe37210-b322-4edb-8ff2-aff9b3e66be0 2022-10-27 Warnings Name fallback generic name: ACETAMINOPHEN Equate 8HR Arthritis Pain Relief ACETAMINOPHEN Wal-Mart Stores Inc ca7f0f68-2862-4265-bf4a-3a89994b4d6b 2022-10-13 Warnings Name fallback generic name: ACETAMINOPHEN Arthritis Pain Relief ACETAMINOPHEN TOPCO ASSOCIATES LLC e60aa992-f5f7-3506-e053-2995a90a7abd 2022-10-04 Warnings Name fallback generic name: ACETAMINOPHEN acetaminophen for children ACETAMINOPHEN Proficient Rx LP 43fd900c-50c8-49c4-9f07-4fef924d533c 2022-09-01 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Hikma Pharmaceuticals USA Inc. b466c989-f7aa-e476-e053-2a95a90a8e55 2022-07-18 Boxed warning, Warnings, Adverse reactions Name fallback generic name: ACETAMINOPHEN topcare 8 hr arthritis pain relief ACETAMINOPHEN Topco Associates LLC 0d427360-ff9d-4e98-b218-6eb6c015dc6a 2022-05-23 Warnings Name fallback generic name: ACETAMINOPHEN basic care acetaminophen ACETAMINOPHEN Amazon.com Services LLC b0c55ac4-0b1a-4411-9df3-6bb64e20ea22 2022-03-23 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Solupharm Pharmazeutische Erzeugnisse GmbH d92be8ae-3173-0a9d-e053-2995a90abc63 2022-03-01 Boxed warning, Warnings, Adverse reactions Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Civica, Inc. 1b5ca3e0-ce08-4e11-9385-9ec22e5abb5b 2022-02-15 Boxed warning, Warnings, Adverse reactions Name fallback generic name: ACETAMINOPHEN Acetaminophen Extended-Release ACETAMINOPHEN Magno-Humphries, Inc. 9d22bedb-9fc9-8421-e053-2a95a90acf4a 2021-10-28 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Sandoz Inc 2884e523-5f12-48d6-98dc-3a80cde524f8 2021-08-23 Boxed warning, Warnings, Adverse reactions Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Westminster Pharmaceuticals, LLC ace5ebac-ec11-4c26-b1e3-954b450ee671 2021-05-04 Warnings Name fallback generic name: ACETAMINOPHEN Nighttime Cold and Flu Relief ACETAMINOPHEN Allegiant Health b97126d7-847d-483e-b3d1-e2b61ab1743f 2020-11-11 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Sandoz Inc 3b4ab1cf-8642-44f5-b3a2-3f1f7c620ce9 2020-05-14 Boxed warning, Warnings, Adverse reactions Name fallback generic name: ACETAMINOPHEN
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0713-0164 ACEPHEN Acetaminophen Cosette Pharmaceuticals, Inc. ANDA Current 0713-0164 ACEPHEN Acetaminophen G&W Laboratories, Inc. ANDA Current 68788-8934 ACEPHEN Acetaminophen Preferred Pharmaceuticals Inc. ANDA Current 76413-302 ACEPHEN Acetaminophen Central Texas Community Health Centers ANDA Current