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 26 of 50 · 998 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DR. SANA PAIN AND FEVER FOR Children ACETAMINOPHEN GADAL Laboratories, Inc 8a22a5ba-8623-4cca-8723-52b495403461 2025-07-23 Warnings Name fallback generic name: ACETAMINOPHEN Duralgina ACETAMINOPHEN Menper Distributors Inc. bb31f66c-80a9-4bdb-983b-cef5d21de5ff 2025-07-22 Warnings Name fallback generic name: ACETAMINOPHEN Gesteira ACETAMINOPHEN Menper Distributors, Inc. 5a907289-564c-491b-98d5-d7f43eaaa1b2 2025-07-22 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Rising Pharma Holdings, Inc. bd5e6804-4df4-4a65-92e4-faa3a0f7c005 2025-07-22 Warnings Name fallback generic name: ACETAMINOPHEN childrens pain and fever ACETAMINOPHEN Meijer Distribution Inc 44d50d79-6e47-429f-8cbe-6fcac4667732 2025-07-18 Warnings Name fallback generic name: ACETAMINOPHEN ADWE Childrens Pain Fever ACETAMINOPHEN RARITAN PHARMACEUTICALS INC 79a3232f-0211-4c8a-acee-4f87e06ffc26 2025-07-17 Warnings Name fallback generic name: ACETAMINOPHEN Pain Reliever ACETAMINOPHEN Walmart Inc. 24d191ca-a0c4-e1a8-e063-6394a90a7a2a 2025-07-16 Warnings Name fallback generic name: ACETAMINOPHEN Pain Relief ACETAMINOPHEN BETTER LIVING BRANDS LLC. f3005d0c-424e-0ab3-e053-2995a90a1c10 2025-07-16 Warnings Name fallback generic name: ACETAMINOPHEN Pain Relief ACETAMINOPHEN Demoulas Super Markets, Inc 397fa6e1-37b2-8f51-e063-6394a90a7b94 2025-07-16 Warnings Name fallback generic name: ACETAMINOPHEN Pain Relief ACETAMINOPHEN Demoulas Super Markets, Inc 39800c27-f39f-cd60-e063-6394a90acd55 2025-07-16 Warnings Name fallback generic name: ACETAMINOPHEN Pain Relief ACETAMINOPHEN Demoulas Super Markets, Inc 397f2b63-733e-5b44-e063-6394a90a9718 2025-07-16 Warnings Name fallback generic name: ACETAMINOPHEN Berkley and Jensen Pain Relief ACETAMINOPHEN BJWC d3ee3341-93b8-487c-921e-2892d213efbb 2025-07-15 Warnings Name fallback generic name: ACETAMINOPHEN Up and Up Childrens acetaminophen ACETAMINOPHEN Target Corporation 25a476a4-9969-49b3-94bf-b076bada4cea 2025-07-10 Warnings Name fallback generic name: ACETAMINOPHEN Tylenol Extra Strength Caplet ACETAMINOPHEN Jones Healthcare Group - Packaging Services, Inc fba711c1-4e69-49b0-8994-97c455aebcb2 2025-07-09 Warnings Name fallback generic name: ACETAMINOPHEN good sense pain relief ACETAMINOPHEN L. Perrigo Company af7ae548-38ad-41d5-b1cb-761cd2e386d3 2025-07-08 Warnings Name fallback generic name: ACETAMINOPHEN topcare pain relief ACETAMINOPHEN Topco Associates LLC 6aca88df-d3b5-4a60-b23b-1e66dc41ee7b 2025-07-08 Warnings Name fallback generic name: ACETAMINOPHEN equate childrens pain and fever ACETAMINOPHEN Wal-Mart Stores Inc f15037a5-4e43-4dd6-93b8-b37a1cc22cd6 2025-07-07 Warnings Name fallback generic name: ACETAMINOPHEN Childrens Acetaminophen Oral Liquid Grape Flavor ACETAMINOPHEN AARNA USA INC. 39347f5d-2d3c-0c23-e063-6294a90a3a46 2025-07-05 Warnings Name fallback generic name: ACETAMINOPHEN Childrens Pain and Fever ACETAMINOPHEN Meijer Distribution Inc be841460-98b4-4448-a494-09ff161fd131 2025-07-02 Warnings Name fallback generic name: ACETAMINOPHEN FeverAll ACETAMINOPHEN Sun Pharmaceutical Industries, Inc. 8970b91b-5f3c-4764-9e23-25dcb398d0a7 2025-07-02 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