Application 216467

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN	ACETAMINOPHEN	SOLUTION;INTRAVENOUS	1GM/100ML (10MG/ML)	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
A216467-001	ACETAMINOPHEN	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS			2022-10-25

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-25	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216467-001	ACETAMINOPHEN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		2022-10-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-01-26 05:58 UTC	2023-01	A216467-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216467-001	AP	1	`3a93d1ddd44b…`

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 47 of 49 · 961 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	B. Braun Medical Inc.	6d763554-913d-4bed-9efd-b9c9b936a2f4	2023-05-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
eight hour pain relief	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	b5fe8873-13c9-402e-b06c-6e679af7267e	2023-05-17	Warnings	Name fallback generic name: ACETAMINOPHEN
pain reliever fever reducer childrens	ACETAMINOPHEN	Walgreen Company	f2085b26-5778-4656-8de3-9edd83f914dd	2023-05-03	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	WG Critical Care, LLC	60f0d5b2-cab4-4a7c-8b53-1526a0908a54	2023-05-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
8 hr Arthritis Pain Relief	ACETAMINOPHEN	DOLGENCORP, INC.	ea2eae7c-e9bd-534c-e053-2a95a90a26c8	2023-04-20	Warnings	Name fallback generic name: ACETAMINOPHEN
8 hr Pain Relief	ACETAMINOPHEN	DOLGENCORP, INC.	ea2ebb7b-ceab-567a-e053-2995a90aa402	2023-04-20	Warnings	Name fallback generic name: ACETAMINOPHEN
HEB	ACETAMINOPHEN	HEB	96b1808f-defa-28cb-e053-2995a90a563b	2023-04-12	Warnings	Name fallback generic name: ACETAMINOPHEN
Arthritis Pain Relief	ACETAMINOPHEN	WINCO FOODS, LLC	f45f43da-b994-2bc8-e053-2995a90a93e0	2023-04-11	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Solupharm Pharmazeutische Erzeugnisse GmbH	adeebc6c-c82f-40dc-b813-1b02244984ce	2023-02-13	Warnings, Adverse reactions	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Pain Relief 8 HR	ACETAMINOPHEN	H E B	b5c7e93b-e626-49c3-a7d4-773475f945ae	2022-11-12	Warnings	Name fallback generic name: ACETAMINOPHEN
arthritis pain relief	ACETAMINOPHEN	Meijer Distribution Inc	c388f3a5-03bb-4fed-b81a-bb876bc260f0	2022-10-27	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	Meijer Distribution Inc	bfe37210-b322-4edb-8ff2-aff9b3e66be0	2022-10-27	Warnings	Name fallback generic name: ACETAMINOPHEN
Equate 8HR Arthritis Pain Relief	ACETAMINOPHEN	Wal-Mart Stores Inc	ca7f0f68-2862-4265-bf4a-3a89994b4d6b	2022-10-13	Warnings	Name fallback generic name: ACETAMINOPHEN
Arthritis Pain Relief	ACETAMINOPHEN	TOPCO ASSOCIATES LLC	e60aa992-f5f7-3506-e053-2995a90a7abd	2022-10-04	Warnings	Name fallback generic name: ACETAMINOPHEN
acetaminophen for children	ACETAMINOPHEN	Proficient Rx LP	43fd900c-50c8-49c4-9f07-4fef924d533c	2022-09-01	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Hikma Pharmaceuticals USA Inc.	b466c989-f7aa-e476-e053-2a95a90a8e55	2022-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
topcare 8 hr arthritis pain relief	ACETAMINOPHEN	Topco Associates LLC	0d427360-ff9d-4e98-b218-6eb6c015dc6a	2022-05-23	Warnings	Name fallback generic name: ACETAMINOPHEN
basic care acetaminophen	ACETAMINOPHEN	Amazon.com Services LLC	b0c55ac4-0b1a-4411-9df3-6bb64e20ea22	2022-03-23	Warnings	Name fallback generic name: ACETAMINOPHEN
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

Reported adverse events (FAERS/openFDA)#

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