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 41 of 51 · 1,003 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES , LLC.	09315a3d-bb2d-4f06-e063-6294a90a3bd3	2024-06-14	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	872365ca-0c6b-550a-e053-2a91aa0ab25a	2024-06-14	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Pain Relief Regular Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	613bc633-0426-41a7-aea9-9ff56311b607	2024-06-13	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	Chain Drug Marketing Association	cfaf9495-e654-4dfc-ba23-d2358c3720c4	2024-06-13	Warnings	Name fallback generic name: ACETAMINOPHEN
8 Hour Pain Relief	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	3ec966f5-bdcb-4bd8-b265-c776ba778f25	2024-06-13	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	9fdbaf5e-f88b-4d18-97df-0b2e8dddf377	2024-06-13	Warnings	Name fallback generic name: ACETAMINOPHEN
8 Hour Arthritis Pain	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	b098ebf6-a76d-4550-b5c4-fdc3b4ceb9a8	2024-06-13	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Extra Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	1ac7ed71-5afe-d09c-e063-6294a90a3b88	2024-06-13	Warnings	Name fallback generic name: ACETAMINOPHEN
8HR Muscle Aches and Pain	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	15abb899-e301-40e6-e063-6294a90a4bac	2024-06-13	Warnings	Name fallback generic name: ACETAMINOPHEN
8HR Muscle Aches and Pain	ACETAMINOPHEN	FSA STORE INC.	13268603-0080-22cf-e063-6394a90a7db4	2024-06-13	Warnings	Name fallback generic name: ACETAMINOPHEN
topcare infants pain and fever	ACETAMINOPHEN	Topco Associates LLC	f1e940ef-3cf0-4a5c-8158-156d0e5a680d	2024-06-13	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Trifecta Pharmaceuticals USA LLC	026bf664-d598-73de-e063-6394a90a9206	2024-06-12	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Regular Strength Pain Relief	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	7c73fc75-af9b-177c-e053-2a91aa0ada56	2024-06-12	Warnings	Name fallback generic name: ACETAMINOPHEN
ACETAMINOPHEN	ACETAMINOPHEN	NCS HealthCare of KY, LLC dba Vangard Labs	3f2eadf9-9bb3-437e-972d-232828ca9d34	2024-06-12	Warnings	Name fallback brand name: ACETAMINOPHEN generic name: ACETAMINOPHEN
pain and fever	ACETAMINOPHEN	Meijer Distribution Inc	cbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf	2024-06-07	Warnings	Name fallback generic name: ACETAMINOPHEN
acetaminophen for children	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	5f86e792-3262-4ee6-e053-2991aa0a54a0	2024-06-06	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	Meijer Distribution Inc	033a6153-2651-4703-8a94-def461838113	2024-06-05	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	BluePoint Laboratories	c065c531-88f5-0930-e053-2a95a90ae861	2024-06-05	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
CareOne Childrens Acetaminophen	ACETAMINOPHEN	American Sales Company	126ee71a-c408-415b-9a43-502337a91055	2024-06-05	Warnings	Name fallback generic name: ACETAMINOPHEN
Tylenol Extra Strength	ACETAMINOPHEN	A-S Medication Solutions	85294a70-3233-4ba5-bc36-ee3f2964aebf	2024-06-05	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

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