Application 071010

Type: ANDA
Sponsor: ACINO PRODS

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
A071010-001	ACETAMINOPHEN	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL			1987-05-12

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	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071010-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-05-12	`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 50 of 51 · 1,003 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Solupharm Pharmazeutische Erzeugnisse GmbH	d92be8ae-3173-0a9d-e053-2995a90abc63	2022-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Civica, Inc.	1b5ca3e0-ce08-4e11-9385-9ec22e5abb5b	2022-02-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Acetaminophen Extended-Release	ACETAMINOPHEN	Magno-Humphries, Inc.	9d22bedb-9fc9-8421-e053-2a95a90acf4a	2021-10-28	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Sandoz Inc	2884e523-5f12-48d6-98dc-3a80cde524f8	2021-08-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Westminster Pharmaceuticals, LLC	ace5ebac-ec11-4c26-b1e3-954b450ee671	2021-05-04	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Nighttime Cold and Flu Relief	ACETAMINOPHEN	Allegiant Health	b97126d7-847d-483e-b3d1-e2b61ab1743f	2020-11-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Sandoz Inc	3b4ab1cf-8642-44f5-b3a2-3f1f7c620ce9	2020-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Aphena Pharma Solutions - Tennessee, LLC	89134c3e-ec5b-4a57-952a-98d6c6cff7c2	2019-02-26	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	TIME CAP LABORATORIES, INC	2569383a-4a05-4ddb-852e-b37e487ffcde	2018-12-17	Warnings	Name fallback brand name: ACETAMINOPHEN generic name: ACETAMINOPHEN
Clear Choice Regular Strength Pain Reliever	ACETAMINOPHEN	Athlete's Needs, Inc.	d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7	2018-12-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Walgreen Company	a1cec332-5802-4684-8b7f-6cb98da40e8b	2018-08-15	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Velocity Pharma LLC	bba2ddc5-19e0-4f11-8ff7-7dd7c2d53b50	2018-05-14	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Advance Pharmaceutical Inc.	3793a17e-13bf-4d27-b8fa-6753b760f820	2017-12-22	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
APAP	ACETAMINOPHEN	Advance Pharmaceutical Inc.	aba26f0a-94e4-4919-a3b0-033e3a9598ef	2017-12-22	Warnings	Name fallback generic name: ACETAMINOPHEN
APAP	ACETAMINOPHEN	Advance Pharmaceutical Inc.	5c75dc7f-06ae-440e-90ed-d7753eaa786e	2017-12-22	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Acetaminophen	ACETAMINOPHEN	PuraCap Pharmaceutical LLC	f3c57374-1408-4459-a4de-ad12c2fc6b61	2017-11-09	Warnings	Name fallback generic name: ACETAMINOPHEN
Extra Strength Acetaminophen	ACETAMINOPHEN	CVS PHARMACY, INC.	3f9c230b-e6ea-4786-992b-9c7204425209	2017-11-09	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Richmond Pharmaceuticals, Inc.	cda8e158-01ac-4c08-826e-4a0c7278e805	2017-10-30	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
APAP	ACETAMINOPHEN	Richmond Pharmaceuticals, Inc.	a30388fa-0d85-4eb3-babd-228170ebe96d	2017-10-30	Warnings	Name fallback generic name: ACETAMINOPHEN
APAP	ACETAMINOPHEN	Richmond Pharmaceuticals, Inc.	ad087586-67cd-4875-b0e6-3fba06ea0f65	2017-10-30	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

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