Application 073108

Type: ANDA
Sponsor: ABLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN	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
A073108-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	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	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073108-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	1995-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073108-001	ACETAMINOPHEN	650MG	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 43 of 51 · 1,003 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
childrens pain and fever	ACETAMINOPHEN	Walgreen Company	928bb80e-2e14-488c-99ab-abb860cbe7a8	2024-05-07	Warnings	Name fallback generic name: ACETAMINOPHEN
basic care childrens pain and fever	ACETAMINOPHEN	Amazon.com Services LLC	790d8883-52be-46f2-9838-564b6c5d57f9	2024-05-07	Warnings	Name fallback generic name: ACETAMINOPHEN
Rugby Childrens Acetaminophen	ACETAMINOPHEN	Rugby Laboratories	304a9aa2-9198-44ca-8627-d41b84ec6cbf	2024-05-07	Warnings	Name fallback generic name: ACETAMINOPHEN
careone childrens acetaminophen	ACETAMINOPHEN	American Sales Company	808f4790-cadd-4285-ae70-25eb547137e2	2024-05-07	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Baxter Healthcare Corporation	0f67c1bd-915b-4681-88dd-22f5154a80b3	2024-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Basic Care Childrens Pain and Fever	ACETAMINOPHEN	Amazon.com Services LLC	bf8bed5d-7dd4-492c-98ac-c36ff8be8f41	2024-05-06	Warnings	Name fallback generic name: ACETAMINOPHEN
Basic Care Childrens Pain and Fever	ACETAMINOPHEN	Amazon.com Services LLC	0c133707-a8b8-4105-82f3-e3855ec19617	2024-05-06	Warnings	Name fallback generic name: ACETAMINOPHEN
leader infants pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	cfbb8553-f3ac-437d-8f63-caa93f257a77	2024-05-06	Warnings	Name fallback generic name: ACETAMINOPHEN
good sense childrens pain and fever	ACETAMINOPHEN	L. Perrigo Company	ab96395c-a19e-40d6-b37e-7f988026fc95	2024-05-06	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	WALGREEN CO.	c20d110a-ed5e-aed4-e053-2a95a90a4200	2024-05-06	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Good Sense pain and fever	ACETAMINOPHEN	L. Perrigo Company	48833e6a-db42-42b8-aa75-07103a1482a2	2024-04-30	Warnings	Name fallback generic name: ACETAMINOPHEN
basic care infants pain and fever	ACETAMINOPHEN	Amazon.com Services LLC	aaa2b462-5ccf-43b0-9d71-71de74653a21	2024-04-29	Warnings	Name fallback generic name: ACETAMINOPHEN
dg health childrens pain and fever	ACETAMINOPHEN	Dolgencorp Inc	49b2ac72-86a3-4783-bf51-8c1a222e457e	2024-04-25	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Fresenius Kabi USA, LLC	a0cece43-256e-4adc-92f8-11a0f473bb83	2024-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
basic care infants pain and fever	ACETAMINOPHEN	Amazon.com Services LLC	dab1f9e6-3875-4d53-a417-c6a78274ee56	2024-04-23	Warnings	Name fallback generic name: ACETAMINOPHEN
Regular Strength Acetaminophen	ACETAMINOPHEN	KROGER COMPANY	0fe995cd-f974-db04-e063-6294a90a3355	2024-04-18	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever Dye Free	ACETAMINOPHEN	KROGER COMPANY	0fec66b4-3a2a-63d1-e063-6294a90a6d72	2024-04-17	Warnings	Name fallback generic name: ACETAMINOPHEN
8 Hour Pain Relief	ACETAMINOPHEN	KROGER COMPANY	0fec5c67-8d5d-8e45-e063-6394a90a982a	2024-04-15	Warnings	Name fallback generic name: ACETAMINOPHEN
childrens acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	243a5cff-e506-434b-ab19-1a6ac53f8533	2024-04-15	Warnings	Name fallback generic name: ACETAMINOPHEN
Dye Free Pain Reliever Childrens	ACETAMINOPHEN	P & L Development, LLC	45ddcaad-d416-4d7c-a84a-43548d5c5d3b	2024-04-15	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

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