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 8 of 51 · 1,003 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INFANTS Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	257436e1-e0f3-4a87-bffe-4f176b836caf	2026-05-27	Warnings	Name fallback generic name: ACETAMINOPHEN
Infants Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	6509a545-0036-460a-8f0d-b31caae17855	2026-05-27	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain and Fever Chewables Childrens	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	bad8ac0a-518d-4639-9b92-a39e0d437238	2026-05-22	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	A-S Medication Solutions	92559d65-f5e2-4054-9763-b9c560452dab	2026-05-22	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Aurohealth LLC	e072e4ab-669d-40ee-b301-0bc15b67792f	2026-05-21	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Grocery Outlet, Inc.	441d1bde-d677-fab7-e063-6394a90aaad4	2026-05-21	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Grocery Outlet, Inc.	441d3a39-cc55-3c7c-e063-6394a90ad7a7	2026-05-21	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Arthritis Pain	ACETAMINOPHEN	Grocery Outlet, Inc.	441d0aa0-9a65-98e9-e063-6294a90a5eb2	2026-05-21	Warnings	Name fallback generic name: ACETAMINOPHEN
INFANTS Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	b3f57af5-661f-4534-9eed-76e431f338db	2026-05-20	Warnings	Name fallback generic name: ACETAMINOPHEN
Infants Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	e837538d-0515-4f99-b04c-fda63b28777e	2026-05-20	Warnings	Name fallback generic name: ACETAMINOPHEN
Genexa Infants Pain and Fever	ACETAMINOPHEN	Genexa Inc.	5220a40d-4a4f-5bad-e063-6394a90a93b0	2026-05-18	Warnings	Name fallback generic name: ACETAMINOPHEN
childrens Pain and Fever	ACETAMINOPHEN	Topco Associates, LLC	7f7b4377-9b40-4a12-808b-f1cd7d241b0d	2026-05-18	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Acetris Pharma Holdings, LLC	dacbe2eb-f412-4629-a8ff-237c7fd10ab6	2026-05-13	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
childrens pain reliever	ACETAMINOPHEN	Valu Merchandisers Company	1d3584e3-f128-4441-b842-aba45053ea53	2026-05-12	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	A-S Medication Solutions	c445c6bb-69a8-492e-b100-ce942707f203	2026-05-12	Warnings	Name fallback generic name: ACETAMINOPHEN
Genexa Kids Pain and Fever	ACETAMINOPHEN	Genexa, Inc.	091dd1e7-2484-cdbf-e063-6394a90a2189	2026-05-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Little Remedies Infant Fever/Pain Reliever	ACETAMINOPHEN	Medtech Products Inc.	af5c3b3b-079f-4ee6-a9a4-a13ee8cd99a5	2026-05-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Extra Strength	ACETAMINOPHEN	CVS PHARMACY	afacdc0b-fb65-464e-91b8-e82ba7ecde44	2026-05-11	Warnings	Name fallback generic name: ACETAMINOPHEN
CHILDRENS PAIN RELIEVER and FEVER REDUCER CHERRY	ACETAMINOPHEN	DeMoulas Market Basket	192f7c24-a4aa-4c05-8d64-5e7e0bf7a101	2026-05-09	Warnings	Name fallback generic name: ACETAMINOPHEN
CHILDRENS PAIN RELIEVER and FEVER REDUCER GRAPE	ACETAMINOPHEN	DeMoulas Market Basket	0ff5c86e-d84b-42ad-b749-636ab2e3734e	2026-05-09	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

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