Home Applications 072237 Application 072237
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 650MG 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 A072237-001 ACEPHEN ACETAMINOPHEN 650MG 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 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072237-001 ACEPHEN 650MG SUPPOSITORY / RECTAL 1992-03-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072237-001 ACEPHEN 650MG 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 40 of 50 · 998 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acetaminophen Extra Strength ACETAMINOPHEN WinCo Foods, LLC c358d1dd-9fcb-4d18-9521-8f898b98a732 2024-07-09 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen Regular Strength ACETAMINOPHEN WinCo Foods, LLC 15430025-f25e-4fe7-b1fe-4eda4684081a 2024-07-09 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen Easy Tabs Extra Strength ACETAMINOPHEN WinCo Foods, LLC 0631f003-4852-4034-a1c5-1552804b1660 2024-07-09 Warnings Name fallback generic name: ACETAMINOPHEN Pain and Fever ACETAMINOPHEN Meijer Distribution Inc 81d4e8f5-2f15-462b-be71-ef05f0b791ab 2024-07-05 Warnings Name fallback generic name: ACETAMINOPHEN Extra Strength Pain Relief ACETAMINOPHEN Bryant Ranch Prepack 31a97a6a-e5c8-429a-b497-330f0d84777d 2024-07-05 Warnings Name fallback generic name: ACETAMINOPHEN pain and fever ACETAMINOPHEN Meijer Distribution Inc 375b2142-3c89-469c-98fd-bd4b63aeaa11 2024-07-05 Warnings Name fallback generic name: ACETAMINOPHEN Topcare pain and fever ACETAMINOPHEN Topco Associates LLC 950b16d5-65db-402d-8ec6-eec9e1e174dd 2024-07-03 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen Extra Strength ACETAMINOPHEN WALMART INC. 16d5b56f-7e56-0c91-e063-6394a90a4b8e 2024-07-03 Warnings Name fallback generic name: ACETAMINOPHEN topcare infants pain and fever ACETAMINOPHEN Topco Associates LLC a1145ac3-3e55-4bd5-a53e-6cf869add9a1 2024-07-02 Warnings Name fallback generic name: ACETAMINOPHEN leader childrens pain and fever ACETAMINOPHEN Cardinal Health 110, LLC. dba Leader 4fb4f4b2-c238-4933-b874-08def3b34a28 2024-06-26 Warnings Name fallback generic name: ACETAMINOPHEN good neighbor pharmacy pain and fever childrens ACETAMINOPHEN Amerisource Bergen ca0833ef-837b-47dc-8676-e016af96622c 2024-06-26 Warnings Name fallback generic name: ACETAMINOPHEN leader childrens pain and fever ACETAMINOPHEN Cardinal Health 110, LLC. dba Leader 4a030c3e-8104-4a0a-98c5-6ab469451f20 2024-06-26 Warnings Name fallback generic name: ACETAMINOPHEN Childrens Acetaminophen ACETAMINOPHEN Padagis Israel Pharmaceuticals Ltd a426dd82-b2d6-405e-b0af-cfb1310a6e19 2024-06-26 Warnings Name fallback generic name: ACETAMINOPHEN Pain Reliever ACETAMINOPHEN WALMART INC. (see also Equate) 7d86a03f-74f4-4b24-b6a6-8747acfe905e 2024-06-26 Warnings Name fallback generic name: ACETAMINOPHEN leader childrens pain and fever ACETAMINOPHEN Cardinal Health 110, LLC. dba Leader 5bcc5da9-7e64-4308-a5be-2f47a8ca774d 2024-06-25 Warnings Name fallback generic name: ACETAMINOPHEN pain relief ACETAMINOPHEN Meijer Distribution Inc 43c3fe72-a4ef-48a6-bc22-a644919c0c5c 2024-06-17 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN RETAIL BUSINESS SERVICES , LLC. 09315a3d-bb2d-4f06-e063-6294a90a3bd3 2024-06-14 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN NuCare Pharmaceuticals,Inc. 872365ca-0c6b-550a-e053-2a91aa0ab25a 2024-06-14 Warnings Name fallback generic name: ACETAMINOPHEN Pain Relief Regular Strength ACETAMINOPHEN CHAIN DRUG MARKETING ASSOCIATION INC 613bc633-0426-41a7-aea9-9ff56311b607 2024-06-13 Warnings Name fallback generic name: ACETAMINOPHEN Pain Relief Extra Strength ACETAMINOPHEN Chain Drug Marketing Association cfaf9495-e654-4dfc-ba23-d2358c3720c4 2024-06-13 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 0713-0165 ACEPHEN Acetaminophen Cosette Pharmaceuticals, Inc. ANDA Current 0713-0165 ACEPHEN Acetaminophen G&W Laboratories, Inc. ANDA Current 0713-0165 ACEPHEN Acetaminophen Cosette Pharmaceuticals, Inc. ANDA Current 55154-8850 Acephen Acetaminophen Cardinal Health ANDA Current