Application 073107

Type: ANDA
Sponsor: ABLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN	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
A073107-001	ACETAMINOPHEN	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL			1995-02-27

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	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073107-001	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	1995-02-27	`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 22 of 51 · 1,003 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Extra Strength Acetaminophen	ACETAMINOPHEN	NuCare Pharmaceuticals, Inc.	41affa1a-5aac-7fc0-e063-6394a90a5557	2025-10-30	Warnings	Name fallback generic name: ACETAMINOPHEN
MAPAP Extra Strength	ACETAMINOPHEN	Major Pharmaceuticals	34a95450-3f04-4de4-9113-73e7bd5724a0	2025-10-29	Warnings	Name fallback generic name: ACETAMINOPHEN
GOODNOW PAIN RELIEF	ACETAMINOPHEN	Gobrands, Inc	4d4a78a5-5a88-4f24-b685-c7c6bb5e989e	2025-10-29	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Rising Pharma Holdings, Inc.	f8237772-7656-49fb-b1de-f8fcb5fa55ee	2025-10-28	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
DG Health Pain Relief	ACETAMINOPHEN	Dolgencorp Inc	42f0c87c-7020-4af7-9f6b-3a774137e564	2025-10-24	Warnings	Name fallback generic name: ACETAMINOPHEN
Meijer Childrens Pain and Fever Reducer	ACETAMINOPHEN	MEIJER DISTRIBUTION INC	b416857a-22d5-4504-9bbc-69ab5429654d	2025-10-24	Warnings	Name fallback generic name: ACETAMINOPHEN
Children Pain and Fever Reliever	ACETAMINOPHEN	MEIJER DISTRIBUTION INC	60012b2b-1c73-4b5f-92de-b6794f7b33ab	2025-10-24	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	TOPCO ASSOCIATES LLC	bbc367cc-6c79-498e-8fca-1347e6ea1a8c	2025-10-22	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Rugby Laboratories	b16ed4ef-689c-4df2-ab6c-207aa8b9925d	2025-10-22	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
M-PAP	ACETAMINOPHEN	Method Pharmaceuticals, LLC	1539dc44-15a0-153b-e063-6294a90a9d45	2025-10-21	Warnings	Name fallback generic name: ACETAMINOPHEN
M-PAP	ACETAMINOPHEN	Method Pharmaceuticals, LLC	3d1bb61c-15db-4eba-aba9-cfbcbc7b30e0	2025-10-21	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	ASCLEMED USA INC.	db8e6702-88ac-4db2-9dd8-7d0ed997c2b5	2025-10-14	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever Extra Strength	ACETAMINOPHEN	Walgreen Company	fa33f6ef-522b-4630-9716-92371d9cd24a	2025-10-14	Warnings	Name fallback generic name: ACETAMINOPHEN
acetaminophen	ACETAMINOPHEN	Rite Aid Corporation	a8bb4f45-7a1a-4bf7-92ca-3afd508032f3	2025-10-09	Warnings	Name fallback brand name: acetaminophen generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	Health Pharma USA LLC	b15a7dcb-f143-4aea-8850-d0aacbf709b6	2025-10-09	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	PD-Rx Pharmaceuticals, Inc.	3f96aeb1-a533-4d36-9a1f-62fc094b6754	2025-10-08	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Care One arthritis pain relief	ACETAMINOPHEN	American Sales Company	c5865a69-4fe4-4f0d-9e03-5927dd737445	2025-10-06	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	004c39cd-b4f4-1cae-e063-6394a90a0697	2025-10-03	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	Family Dollar (FAMILY WELLNESS)	43573e35-6776-446e-aa28-75c8edc5b98d	2025-10-03	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	Family Dollar (FAMILY WELLNESS)	f8e5fab4-1212-4c60-a160-9b782f76a198	2025-10-03	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.