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 43 of 50 · 998 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acetaminophen ACETAMINOPHEN Baxter Healthcare Corporation 0f67c1bd-915b-4681-88dd-22f5154a80b3 2024-05-06 Boxed warning, Warnings, Adverse reactions Name fallback generic name: ACETAMINOPHEN Basic Care Childrens Pain and Fever ACETAMINOPHEN Amazon.com Services LLC bf8bed5d-7dd4-492c-98ac-c36ff8be8f41 2024-05-06 Warnings Name fallback generic name: ACETAMINOPHEN Basic Care Childrens Pain and Fever ACETAMINOPHEN Amazon.com Services LLC 0c133707-a8b8-4105-82f3-e3855ec19617 2024-05-06 Warnings Name fallback generic name: ACETAMINOPHEN leader infants pain and fever ACETAMINOPHEN Cardinal Health 110, LLC. dba Leader cfbb8553-f3ac-437d-8f63-caa93f257a77 2024-05-06 Warnings Name fallback generic name: ACETAMINOPHEN good sense childrens pain and fever ACETAMINOPHEN L. Perrigo Company ab96395c-a19e-40d6-b37e-7f988026fc95 2024-05-06 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN WALGREEN CO. c20d110a-ed5e-aed4-e053-2a95a90a4200 2024-05-06 Warnings Name fallback generic name: ACETAMINOPHEN Good Sense pain and fever ACETAMINOPHEN L. Perrigo Company 48833e6a-db42-42b8-aa75-07103a1482a2 2024-04-30 Warnings Name fallback generic name: ACETAMINOPHEN basic care infants pain and fever ACETAMINOPHEN Amazon.com Services LLC aaa2b462-5ccf-43b0-9d71-71de74653a21 2024-04-29 Warnings Name fallback generic name: ACETAMINOPHEN dg health childrens pain and fever ACETAMINOPHEN Dolgencorp Inc 49b2ac72-86a3-4783-bf51-8c1a222e457e 2024-04-25 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Fresenius Kabi USA, LLC a0cece43-256e-4adc-92f8-11a0f473bb83 2024-04-24 Boxed warning, Warnings, Adverse reactions Name fallback generic name: ACETAMINOPHEN basic care infants pain and fever ACETAMINOPHEN Amazon.com Services LLC dab1f9e6-3875-4d53-a417-c6a78274ee56 2024-04-23 Warnings Name fallback generic name: ACETAMINOPHEN Regular Strength Acetaminophen ACETAMINOPHEN KROGER COMPANY 0fe995cd-f974-db04-e063-6294a90a3355 2024-04-18 Warnings Name fallback generic name: ACETAMINOPHEN Childrens Pain and Fever Dye Free ACETAMINOPHEN KROGER COMPANY 0fec66b4-3a2a-63d1-e063-6294a90a6d72 2024-04-17 Warnings Name fallback generic name: ACETAMINOPHEN 8 Hour Pain Relief ACETAMINOPHEN KROGER COMPANY 0fec5c67-8d5d-8e45-e063-6394a90a982a 2024-04-15 Warnings Name fallback generic name: ACETAMINOPHEN childrens acetaminophen ACETAMINOPHEN Major Pharmaceuticals 243a5cff-e506-434b-ab19-1a6ac53f8533 2024-04-15 Warnings Name fallback generic name: ACETAMINOPHEN Dye Free Pain Reliever Childrens ACETAMINOPHEN P & L Development, LLC 45ddcaad-d416-4d7c-a84a-43548d5c5d3b 2024-04-15 Warnings Name fallback generic name: ACETAMINOPHEN Tylenol Extra Strength ACETAMINOPHEN Navajo Manufacturing Company Inc. 65bf1556-f25a-9439-e053-2a91aa0a3194 2024-04-15 Warnings Name fallback generic name: ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN Kroger Company bbeebdd6-fe2c-5b8a-e053-2a95a90ab95e 2024-04-13 Warnings Name fallback generic name: ACETAMINOPHEN infants pain relief ACETAMINOPHEN Publix Super Markets Inc 3d1818a7-d3b2-434c-b3c9-b2713f08ded2 2024-04-13 Warnings Name fallback generic name: ACETAMINOPHEN Mommys Bliss Childrens Pain and Fever ACETAMINOPHEN Mom Enterprises, LLC. 08b9eaf7-70d1-640f-e063-6394a90a8d3b 2024-04-12 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