Application 073106

Type: ANDA
Sponsor: ABLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN	ACETAMINOPHEN	SUPPOSITORY;RECTAL	120MG	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
A073106-001	ACETAMINOPHEN	ACETAMINOPHEN	120MG	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	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073106-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1995-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073106-001	ACETAMINOPHEN	120MG	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 6 of 51 · 1,003 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Reliever	ACETAMINOPHEN	Orelli Inc.	4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d	2026-06-22	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	DOLGENCORP, LLC	acc94a3e-21b6-4375-9881-38cf9bab8692	2026-06-19	Warnings	Name fallback generic name: ACETAMINOPHEN
dg health 8 hr arthritis pain relief	ACETAMINOPHEN	Dolgencorp Inc	fc7838a7-fc6d-41b7-b8e4-97bee2bfa6d4	2026-06-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Neo-Lubrina Children	ACETAMINOPHEN	OPMX LLC	5476f4cf-4a5d-2287-e063-6394a90a5ed5	2026-06-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Oncor Pharmaceuticals	4c396d0e-aa93-4f9e-b065-2e606f7f05cd	2026-06-17	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Mejoralito Children	ACETAMINOPHEN	OPMX LLC	5464188d-0137-033e-e063-6294a90ace66	2026-06-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever Relief	ACETAMINOPHEN	Chain Drug Marketing Association, Inc.	420a1e05-caa6-481f-bdab-a670f0220f96	2026-06-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	DOLGENCORP, LLC	ce9f4e0d-43fb-499a-b8a2-a997a14841c4	2026-06-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	L.N.K. International, Inc.	734cc3d2-6fc5-4dcc-93ed-0b57c1f01345	2026-06-15	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	00eb3e4b-1507-4c9a-83a5-ef50cb312753	2026-06-15	Warnings	Name fallback brand name: ACETAMINOPHEN generic name: ACETAMINOPHEN
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	59773893-09a8-47a2-943a-e9ea9da4458a	2026-06-15	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	Shield Pharmaceuticals Corp.	96eb7f9f-ff2d-4661-bbe6-1860aafe03f6	2026-06-15	Warnings	Name fallback generic name: ACETAMINOPHEN
Duralgina Extra Strength	ACETAMINOPHEN	Menper Distributors, Inc.	544e3d7e-a759-384f-e063-6294a90a5baa	2026-06-15	Warnings	Name fallback generic name: ACETAMINOPHEN
DESENFRIOL-ITO PLUS	ACETAMINOPHEN	OPMX LLC	544ee7bd-0c95-2485-e063-6294a90a98c7	2026-06-15	Warnings	Name fallback generic name: ACETAMINOPHEN
pain relief childrens	ACETAMINOPHEN	Rite Aid Corporation	be2286a1-946b-4bf5-b14c-8e86da669594	2026-06-15	Warnings	Name fallback generic name: ACETAMINOPHEN
CHILDRENS TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	3162733b-9382-39f1-e063-6294a90ac420	2026-06-12	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Extra Strength	ACETAMINOPHEN	Dr. Reddy's Laboratories Inc.	9769e0c0-2f4c-3b7a-1a65-c98fbce11681	2026-06-12	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	NuCare Pharmaceuticals, Inc.	54010ddf-25d1-2016-e063-6294a90a877d	2026-06-11	Warnings	Name fallback brand name: ACETAMINOPHEN generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	983debdf-4a61-4dde-ba34-567fdd17720e	2026-06-11	Warnings	Name fallback brand name: ACETAMINOPHEN generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	PUBLIX SUPERMARKETS, INC	3f17fa06-4932-b8ec-e063-6294a90a0381	2026-06-09	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

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