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 42 of 51 · 1,003 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acetaminophen for children	ACETAMINOPHEN	NuCare Pharmaceutiacals,Inc.	5d7ef1d2-d970-7b01-e053-2991aa0a1311	2024-06-04	Warnings	Name fallback generic name: ACETAMINOPHEN
CareOne Infants Acetaminophen	ACETAMINOPHEN	American Sales Company	0a28a4f1-d947-489b-be28-36ba10b581cf	2024-06-01	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Bryant Ranch Prepack	77fb237f-28b5-486b-b9ef-cb324d5cc0bd	2024-05-30	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Bryant Ranch Prepack	b5053cf5-209d-4106-afc2-cf9af85f4a69	2024-05-29	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
topcare infants pain and fever	ACETAMINOPHEN	Topco Associates LLC	f129bc0e-1ef1-42a8-8668-2ee88ffc85e3	2024-05-23	Warnings	Name fallback generic name: ACETAMINOPHEN
Good Neighbor Pharmacy Childrens Pain and Fever	ACETAMINOPHEN	Amerisource Bergen	074fdf65-f6ce-46d4-87cc-46911c01cca5	2024-05-23	Warnings	Name fallback generic name: ACETAMINOPHEN
DG Health Childrens Pain and Fever	ACETAMINOPHEN	Dolgencorp, LLC	779cf607-245f-408a-81e8-8000c0ea4c4a	2024-05-22	Warnings	Name fallback generic name: ACETAMINOPHEN
good sense pain and fever infants	ACETAMINOPHEN	L. Perrigo Company	7b4c7e4c-1536-45ab-a59b-4d5dd8eb2eb4	2024-05-21	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Solution	ACETAMINOPHEN	Patrin Pharma, Inc.	52ae729b-2255-420c-8db8-cabdc2b74796	2024-05-21	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	QUALITY CHOICE (Chain Drug Marketing Association)	2f9da3d6-229d-44d1-bd94-4bcddbbdb120	2024-05-20	Warnings	Name fallback generic name: ACETAMINOPHEN
AMAZON BASIC CARE ACETAMINOPHEN	ACETAMINOPHEN	Amazon.com Services LLC	10ee2f40-858d-bed4-e063-6394a90a86bb	2024-05-17	Warnings	Name fallback generic name: ACETAMINOPHEN
TYLENOL EXTRA STRENGTH	ACETAMINOPHEN	A-S Medication Solutions	bcb7eb24-16cb-439e-879f-48d2f5e8ba83	2024-05-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Basic Care Childrens Pain and Fever	ACETAMINOPHEN	Amazon.com Services LLC	26266777-185d-4110-a8a7-56846aab2542	2024-05-17	Warnings	Name fallback generic name: ACETAMINOPHEN
TYLENOL EXTRA STRENGTH	ACETAMINOPHEN	A-S Medication Solutions	1b4db77f-b254-4db5-8e98-d46850140a9b	2024-05-16	Warnings	Name fallback generic name: ACETAMINOPHEN
KOSHER MEDS Childrens Pain and Fever	ACETAMINOPHEN	Mollec Inc	4d01c9ee-26be-4cdd-b52d-7fa344c1933a	2024-05-15	Warnings	Name fallback generic name: ACETAMINOPHEN
AMAZON BASIC CARE ACETAMINOPHEN	ACETAMINOPHEN	Amazon.com Services LLC	113df1bc-a217-33ea-e063-6294a90a4643	2024-05-14	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	P & L Development, LLC	1c081a7c-8cff-4253-97ac-5fa74a5c0668	2024-05-10	Warnings	Name fallback generic name: ACETAMINOPHEN
dg health childrens pain and fever	ACETAMINOPHEN	Dolgencorp Inc	1d794621-9836-4ab8-92ee-fcd916964567	2024-05-09	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	76cb8209-6c43-322e-e053-2991aa0a51eb	2024-05-08	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
basic care infants pain and fever	ACETAMINOPHEN	Amazon.com Services LLC	40329d8c-eb3d-4143-b4ae-9bafd0a1cb3c	2024-05-08	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

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