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 35 of 50 · 998 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join equate infants pain and fever ACETAMINOPHEN WALMART INC. 34b2512e-743b-45db-92cb-ea05e2f47b3d 2024-10-31 Warnings Name fallback generic name: ACETAMINOPHEN foster and thrive infants pain and fever ACETAMINOPHEN Strategic Sourcing Services LLC 45770ad6-9bf7-41bd-a724-e5260cd31fa1 2024-10-31 Warnings Name fallback generic name: ACETAMINOPHEN up and up infants acetaminophen ACETAMINOPHEN Target Corporation 31104956-04d7-41b5-82be-219ded5c02a9 2024-10-30 Warnings Name fallback generic name: ACETAMINOPHEN welby acetaminophen ACETAMINOPHEN Aldi, Inc 7e09702c-52d4-490d-a320-13a1ab422100 2024-10-30 Warnings Name fallback generic name: ACETAMINOPHEN Good Neighbor Pharmacy Pain Relief ACETAMINOPHEN Amerisource Bergen 5101125d-4819-4e4b-a0ee-a0ff8d5a0ab1 2024-10-30 Warnings Name fallback generic name: ACETAMINOPHEN Junior Acetaminophen Ages 6-11 ACETAMINOPHEN Chain Drug Consortium d356bc9c-66f1-45c3-a455-98c0b8890f78 2024-10-28 Warnings Name fallback generic name: ACETAMINOPHEN leader Acetaminophen ACETAMINOPHEN Cardinal Health 110, LLC. dba Leader 36bdcac9-eed4-40f9-a6f2-4c1e773a6b50 2024-10-25 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Kroger Company 5bfd9841-c781-43be-b823-d334893ae6ed 2024-10-24 Warnings Name fallback generic name: ACETAMINOPHEN Pain Relief ACETAMINOPHEN H E B add6952e-9dd5-487c-93e6-337e9d6a4872 2024-10-24 Warnings Name fallback generic name: ACETAMINOPHEN Dye Free Pain Reliever Childrens ACETAMINOPHEN Safeway, Inc. 7d55cb42-295f-473a-941d-71825b44a3c0 2024-10-24 Warnings Name fallback generic name: ACETAMINOPHEN rapid release pain relief ACETAMINOPHEN Publix Super Markets Inc d0b34133-d69d-47db-bf51-be942769c612 2024-10-24 Warnings Name fallback generic name: ACETAMINOPHEN basic care acetaminophen ACETAMINOPHEN Amazon.com Services LLC 00146b91-008d-4b16-95b0-6077f98821be 2024-10-24 Warnings Name fallback generic name: ACETAMINOPHEN equate pain reliever ACETAMINOPHEN WALMART INC. 9a20273e-a4d1-4c38-9efb-e6347f8dc14e 2024-10-24 Warnings Name fallback generic name: ACETAMINOPHEN Pain Relief Extra Strength ACETAMINOPHEN MARC GLASSMAN, INC. e221905b-a795-c067-e053-2a95a90a02e7 2024-10-23 Warnings Name fallback generic name: ACETAMINOPHEN Pain Relief Extra Strength ACETAMINOPHEN MARC GLASSMAN, INC. e231c2f6-927c-1ab0-e053-2995a90a6121 2024-10-23 Warnings Name fallback generic name: ACETAMINOPHEN Pain Relief Extra Strength ACETAMINOPHEN MARC GLASSMAN, INC. e23703bb-6087-7985-e053-2995a90aa5ec 2024-10-23 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN HARRIS TEETER 43308b23-7d4f-4e4f-a497-af71920d86aa 2024-10-22 Warnings Name fallback generic name: ACETAMINOPHEN Pain Relief Regular Strength ACETAMINOPHEN MARC GLASSMAN, INC. e21e821c-9694-5db0-e053-2995a90ad034 2024-10-22 Warnings Name fallback generic name: ACETAMINOPHEN Pain Relief Extra Strength ACETAMINOPHEN MARC GLASSMAN, INC. e21e90e8-b9f1-1133-e053-2995a90a664b 2024-10-22 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen Extra Strength ACETAMINOPHEN KROGER COMPANY b96a2280-ec4f-7c61-e053-2995a90a18bb 2024-10-22 Warnings 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