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 38 of 50 · 998 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
childrens fever reducer and pain reliever	ACETAMINOPHEN	Rite Aid Corporation	f6e51c4b-2941-4862-8262-bd9716324841	2024-10-02	Warnings	Name fallback generic name: ACETAMINOPHEN
Good Sense Pain Relief	ACETAMINOPHEN	A-S Medication Solutions	d9bebb47-6ff4-4ddc-b48f-18f942373484	2024-09-30	Warnings	Name fallback generic name: ACETAMINOPHEN
basic care acetaminophen	ACETAMINOPHEN	Amazon.com Services LLC	24fca5f8-1c08-4d1f-8e2c-dc274c4bcd79	2024-09-29	Warnings	Name fallback generic name: ACETAMINOPHEN
pain and fever	ACETAMINOPHEN	Meijer Distribution Inc	eef2fef5-34b3-4ac2-94cb-5bd6b4c5ab1c	2024-09-27	Warnings	Name fallback generic name: ACETAMINOPHEN
good sense childrens pain and fever	ACETAMINOPHEN	A-S Medication Solutions	ce4ae43b-4ec2-42d1-b665-9114aaeb857e	2024-09-26	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	d8aa3b1a-5f63-49db-998c-35cd11bd733f	2024-09-25	Warnings	Name fallback generic name: ACETAMINOPHEN
Good Sense Pain Relief	ACETAMINOPHEN	L. Perrigo Company	7f2038d3-9c95-4d83-b459-49ba8a3cd0ad	2024-09-23	Warnings	Name fallback generic name: ACETAMINOPHEN
pain relief extra strength	ACETAMINOPHEN	Publix Super Markets Inc	dd01adcd-26a1-416e-92fc-8b6c0cc5512e	2024-09-23	Warnings	Name fallback generic name: ACETAMINOPHEN
Signature Care Pain Relief	ACETAMINOPHEN	Safeway	917bcd06-6dc6-42b3-80b4-c6746b347261	2024-09-22	Warnings	Name fallback generic name: ACETAMINOPHEN
equaline childrens acetaminophen	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	1e0cbb47-08f6-4afb-ad5a-6ce1b262ab97	2024-09-19	Warnings	Name fallback generic name: ACETAMINOPHEN
foster and thrive childrens pain and fever	ACETAMINOPHEN	Strategic Sourcing Services LLC	0a4b10e3-29df-40a5-a3fa-0e9beeadfbb4	2024-09-19	Warnings	Name fallback generic name: ACETAMINOPHEN
good sense childrens pain and fever	ACETAMINOPHEN	L. Perrigo Company	61a88a72-cf4f-4ec9-bc24-e110adfb98ba	2024-09-19	Warnings	Name fallback generic name: ACETAMINOPHEN
childrens pain and fever	ACETAMINOPHEN	Walgreen Company	550c4229-c3a3-442c-a9ed-2d04cd4bad51	2024-09-14	Warnings	Name fallback generic name: ACETAMINOPHEN
rexall pain relief	ACETAMINOPHEN	Dolgencorp, LLC	9783cf37-3a2b-4ca1-b4eb-6d6ba047a325	2024-09-12	Warnings	Name fallback generic name: ACETAMINOPHEN
pain relief	ACETAMINOPHEN	H E B	3258ef39-c36e-4a97-8631-89b8d4caf058	2024-09-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Parents Choice Infants Pain and Fever	ACETAMINOPHEN	Wal-Mart Stores Inc	30a51b90-a565-4e38-82ee-b5af29762977	2024-09-10	Warnings	Name fallback generic name: ACETAMINOPHEN
signature care infants pain relief	ACETAMINOPHEN	Safeway	236df05a-cf11-42f3-a347-b54f5113680c	2024-09-10	Warnings	Name fallback generic name: ACETAMINOPHEN
TYLENOL 8 HR ARTHRITIS PAIN	ACETAMINOPHEN	Kenvue Brands LLC	0391963c-022d-1433-e063-6294a90aac90	2024-09-09	Warnings	Name fallback generic name: ACETAMINOPHEN
pain relief	ACETAMINOPHEN	Meijer Distribution Inc	d2759fa6-59cd-417e-8761-d2b129aad8b8	2024-09-09	Warnings	Name fallback generic name: ACETAMINOPHEN
M-PAP	ACETAMINOPHEN	Bryant Ranch Prepack	d344479b-80c1-4592-acc8-3f12690c839c	2024-09-06	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