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	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 16 of 50 · 998 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	Pioneer Life Sciences, LLC	0d67bb52-7ae3-439e-9e47-4e21eb0ca352	2025-12-23	Warnings	Name fallback generic name: ACETAMINOPHEN
Members Mark Arthritis Pain	ACETAMINOPHEN	Sam's West Inc	4cbe2880-fea9-4d7b-9e7f-a0c794864a84	2025-12-23	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	Pioneer Life Sciences, LLC	11e6ec2a-5171-4496-a15f-6ff744bd1f2f	2025-12-23	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Granules USA, Inc	a1255f60-b9c6-9a95-e053-2995a90a9e80	2025-12-22	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Granules USA, Inc	a51395ea-e038-dc9c-e053-2a95a90a287d	2025-12-22	Warnings	Name fallback generic name: ACETAMINOPHEN
CareALL Acetaminophen	ACETAMINOPHEN	New World Imports, Inc	1148b4d9-fa6a-49e6-9663-17b2c8373846	2025-12-22	Warnings	Name fallback generic name: ACETAMINOPHEN
Vitapirena	ACETAMINOPHEN	Pharmadel LLC	0547bc1f-d000-f5a6-e063-6294a90ac73d	2025-12-22	Warnings	Name fallback generic name: ACETAMINOPHEN
CareALL Acetaminophen Extra Strength	ACETAMINOPHEN	New World Imports, Inc	f818417e-0b31-4fe7-8313-4160a00b248a	2025-12-22	Warnings	Name fallback generic name: ACETAMINOPHEN
CareALL Acetaminophen	ACETAMINOPHEN	New World Imports, Inc	c4f82ed8-b82c-47bb-9ab9-108a13d29cf7	2025-12-22	Warnings	Name fallback generic name: ACETAMINOPHEN
CareALL Acetaminophen Extra Strength	ACETAMINOPHEN	New World Imports, Inc	5103450a-3095-49cc-9823-4fb4c1d258ff	2025-12-22	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Granules USA, Inc.	96131c7b-bdff-0642-e053-2a95a90a4f32	2025-12-22	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	WAL-MART STORES INC	940936ac-e59f-7489-e053-2a95a90a6364	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	WAL-MART STORES INC	e34d07b5-ccbb-cd14-e053-2a95a90a394b	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Walmart	175495fd-c561-f813-e063-6294a90aac80	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	WALMART INC	21b22e9f-b6d1-1819-e063-6294a90ae09c	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	MEIJER DISTRIBUTION INC	ed23c587-7806-1f64-e053-2a95a90aea7f	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	MEIJER, INC.	ed25620f-e39b-e30c-e053-2995a90af621	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Meijer	181b3148-fa33-c650-e063-6294a90a0de6	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES,LLC.	a0fb0afe-9c25-d0f6-e053-2995a90adbba	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	TOPCO ASSOCIATES LLC	1a00a49e-f9ff-b928-e063-6394a90a4cb5	2025-12-19	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