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 48 of 48 · 956 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acetaminophen ACETAMINOPHEN Aphena Pharma Solutions - Tennessee, LLC 89134c3e-ec5b-4a57-952a-98d6c6cff7c2 2019-02-26 Warnings Name fallback generic name: ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN TIME CAP LABORATORIES, INC 2569383a-4a05-4ddb-852e-b37e487ffcde 2018-12-17 Warnings Name fallback generic name: ACETAMINOPHEN Clear Choice Regular Strength Pain Reliever ACETAMINOPHEN Athlete's Needs, Inc. d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7 2018-12-11 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Walgreen Company a1cec332-5802-4684-8b7f-6cb98da40e8b 2018-08-15 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Velocity Pharma LLC bba2ddc5-19e0-4f11-8ff7-7dd7c2d53b50 2018-05-14 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Advance Pharmaceutical Inc. 3793a17e-13bf-4d27-b8fa-6753b760f820 2017-12-22 Warnings Name fallback generic name: ACETAMINOPHEN APAP ACETAMINOPHEN Advance Pharmaceutical Inc. aba26f0a-94e4-4919-a3b0-033e3a9598ef 2017-12-22 Warnings Name fallback generic name: ACETAMINOPHEN APAP ACETAMINOPHEN Advance Pharmaceutical Inc. 5c75dc7f-06ae-440e-90ed-d7753eaa786e 2017-12-22 Warnings Name fallback generic name: ACETAMINOPHEN Extra Strength Acetaminophen ACETAMINOPHEN PuraCap Pharmaceutical LLC f3c57374-1408-4459-a4de-ad12c2fc6b61 2017-11-09 Warnings Name fallback generic name: ACETAMINOPHEN Extra Strength Acetaminophen ACETAMINOPHEN CVS PHARMACY, INC. 3f9c230b-e6ea-4786-992b-9c7204425209 2017-11-09 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen ACETAMINOPHEN Richmond Pharmaceuticals, Inc. cda8e158-01ac-4c08-826e-4a0c7278e805 2017-10-30 Warnings Name fallback generic name: ACETAMINOPHEN APAP ACETAMINOPHEN Richmond Pharmaceuticals, Inc. a30388fa-0d85-4eb3-babd-228170ebe96d 2017-10-30 Warnings Name fallback generic name: ACETAMINOPHEN APAP ACETAMINOPHEN Richmond Pharmaceuticals, Inc. ad087586-67cd-4875-b0e6-3fba06ea0f65 2017-10-30 Warnings Name fallback generic name: ACETAMINOPHEN Chewable Acetaminophen Childrens ACETAMINOPHEN Richmond Pharmaceuticals, Inc. a5dd9031-a960-4a98-ab71-05b079183f1a 2017-10-30 Warnings Name fallback generic name: ACETAMINOPHEN Childrens Tukol Acetaminophen Fever Reducer Pain Reducer ACETAMINOPHEN Genomma Lab USA, Inc. 0540111a-fcde-492d-9ed5-bbd714b2acf0 2017-04-15 Warnings Name fallback generic name: ACETAMINOPHEN Acetaminophen Caplets ACETAMINOPHEN Breeden Brothers, LLC 57fff3dc-ba30-4d3d-9362-01df6974f813 2017-02-15 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