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 26 of 51 · 1,003 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DR. SANA PAIN AND FEVER FOR Children	ACETAMINOPHEN	GADAL Laboratories, Inc	8a22a5ba-8623-4cca-8723-52b495403461	2025-07-23	Warnings	Name fallback generic name: ACETAMINOPHEN
Duralgina	ACETAMINOPHEN	Menper Distributors Inc.	bb31f66c-80a9-4bdb-983b-cef5d21de5ff	2025-07-22	Warnings	Name fallback generic name: ACETAMINOPHEN
Gesteira	ACETAMINOPHEN	Menper Distributors, Inc.	5a907289-564c-491b-98d5-d7f43eaaa1b2	2025-07-22	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Rising Pharma Holdings, Inc.	bd5e6804-4df4-4a65-92e4-faa3a0f7c005	2025-07-22	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
childrens pain and fever	ACETAMINOPHEN	Meijer Distribution Inc	44d50d79-6e47-429f-8cbe-6fcac4667732	2025-07-18	Warnings	Name fallback generic name: ACETAMINOPHEN
ADWE Childrens Pain Fever	ACETAMINOPHEN	RARITAN PHARMACEUTICALS INC	79a3232f-0211-4c8a-acee-4f87e06ffc26	2025-07-17	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	Walmart Inc.	24d191ca-a0c4-e1a8-e063-6394a90a7a2a	2025-07-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	BETTER LIVING BRANDS LLC.	f3005d0c-424e-0ab3-e053-2995a90a1c10	2025-07-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	Demoulas Super Markets, Inc	397fa6e1-37b2-8f51-e063-6394a90a7b94	2025-07-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	Demoulas Super Markets, Inc	39800c27-f39f-cd60-e063-6394a90acd55	2025-07-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	Demoulas Super Markets, Inc	397f2b63-733e-5b44-e063-6394a90a9718	2025-07-16	Warnings	Name fallback generic name: ACETAMINOPHEN
Berkley and Jensen Pain Relief	ACETAMINOPHEN	BJWC	d3ee3341-93b8-487c-921e-2892d213efbb	2025-07-15	Warnings	Name fallback generic name: ACETAMINOPHEN
Up and Up Childrens acetaminophen	ACETAMINOPHEN	Target Corporation	25a476a4-9969-49b3-94bf-b076bada4cea	2025-07-10	Warnings	Name fallback generic name: ACETAMINOPHEN
Tylenol Extra Strength Caplet	ACETAMINOPHEN	Jones Healthcare Group - Packaging Services, Inc	fba711c1-4e69-49b0-8994-97c455aebcb2	2025-07-09	Warnings	Name fallback generic name: ACETAMINOPHEN
good sense pain relief	ACETAMINOPHEN	L. Perrigo Company	af7ae548-38ad-41d5-b1cb-761cd2e386d3	2025-07-08	Warnings	Name fallback generic name: ACETAMINOPHEN
topcare pain relief	ACETAMINOPHEN	Topco Associates LLC	6aca88df-d3b5-4a60-b23b-1e66dc41ee7b	2025-07-08	Warnings	Name fallback generic name: ACETAMINOPHEN
equate childrens pain and fever	ACETAMINOPHEN	Wal-Mart Stores Inc	f15037a5-4e43-4dd6-93b8-b37a1cc22cd6	2025-07-07	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Acetaminophen Oral Liquid Grape Flavor	ACETAMINOPHEN	AARNA USA INC.	39347f5d-2d3c-0c23-e063-6294a90a3a46	2025-07-05	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	Meijer Distribution Inc	be841460-98b4-4448-a494-09ff161fd131	2025-07-02	Warnings	Name fallback generic name: ACETAMINOPHEN
FeverAll	ACETAMINOPHEN	Sun Pharmaceutical Industries, Inc.	8970b91b-5f3c-4764-9e23-25dcb398d0a7	2025-07-02	Warnings	Name fallback generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

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