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	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 17 of 50 · 998 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES,LLC.	a56791ec-0037-51a3-e053-2995a90af761	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	RAONBIO CORP	f6f5251d-db89-4b69-e053-6394a90a1028	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	WALGREENS	8f8d43d1-8e73-483e-e053-2a95a90ac99b	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	PUBLIX SUPERMARKETS, INC	08f57305-0c4b-96b1-e063-6394a90a77df	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	WALGREENS CO.	8dba6ae0-1bfb-84de-e053-2a95a90aae46	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	LEADER/ Cardinal Health 110, Inc	f797848e-f23f-997b-e053-6394a90aae55	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	MAJOR PHARMACEUTICALS	efd0a432-abbb-1f88-e053-2995a90a8ce5	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	WALGREEN CO.	b8a855ae-c0a3-0b05-e053-2a95a90ac8a8	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	LEADER/ Cardinal Health 110, Inc	f5dc335d-d3cf-ba94-e053-2a95a90ac6d3	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	Marc Glassman, Inc.	f708e1ec-cf2a-4e2b-851f-f6b703f359b2	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	WALGREEN CO.	b375de90-25c7-aa55-e053-2995a90a3cf8	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	TARGET CORPORATION	e64a3c32-5466-0662-e053-2a95a90ae963	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	SAM'S WEST INC	0c8e7095-0806-4501-e063-6394a90a89aa	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	SAM'S WEST INC	e77c2bc7-0258-4a6d-e053-2a95a90afe6e	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	WALGREENS	e467b78e-9f23-5563-e053-2a95a90a586e	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	CVS PHARMACY iNC	90cea23f-5ddb-7a36-e053-2a95a90a20cf	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	CVS PHARMACY, INC	1ddb8a2b-3081-3eda-e063-6294a90ab82b	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	CVS PHARMACY, INC	b1307d52-10e6-46e1-e053-2995a90a03b6	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	CVS PHARMACY, INC	c2c6d6a1-b492-506d-e053-2995a90aac23	2025-12-19	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Walgreens	0944a5d4-2ccc-5f0d-e063-6394a90a8af9	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
0713-0164	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