Application 211695

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	ACETAMINOPHEN; ASPIRIN; CAFFEINE	TABLET;ORAL	250MG;250MG;65MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	ACETAMINOPHEN; ASPIRIN; CAFFEINE	250MG;250MG;65MG	TABLET / ORAL			2022-02-02

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211695-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2022-02-02	`a50c72e98297…`

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 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMAZON BASIC CARE MIGRAINE RELIEF	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Amazon.com Services LLC	113e8e06-16f2-9341-e063-6294a90af349	2024-05-15	Warnings	Exact identifier application applno (ANDA): 211695 application number: ANDA211695
ACETAMINOPHEN ASPIRIN AND CAFFEINE	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	WALMART INC.	12942e9e-1385-5914-e063-6294a90aceac	2024-03-05	Warnings	Exact identifier application applno (ANDA): 211695 application number: ANDA211695
ACETAMINOPHEN ASPIRIN AND CAFFEINE	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Aurohealth LLC	f5465419-1453-4ccc-a517-1fdff1eb3c05	2023-12-01	Warnings	Exact identifier application applno (ANDA): 211695 application number: ANDA211695 ndc (product): 58602-882
ACETAMINOPHEN ASPIRIN AND CAFFEINE	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Better Living Brands, LLC	f8050cae-8619-f49b-e053-6294a90ad9e6	2023-08-17	Warnings	Exact identifier application applno (ANDA): 211695 application number: ANDA211695
ACETAMINOPHEN ASPIRIN AND CAFFEINE	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Aurohealth LLC	e47e2169-4b31-4c23-bb9d-c26aa106ea37	2023-05-11	Warnings	Exact identifier application applno (ANDA): 211695 application number: ANDA211695 ndc (product): 58602-817

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58602-817	ACETAMINOPHEN ASPIRIN AND CAFFEINE	acetaminophen, aspirin and caffeine	Aurohealth LLC	ANDA	Current
58602-817	ACETAMINOPHEN ASPIRIN AND CAFFEINE	acetaminophen, aspirin and caffeine	Aurohealth LLC	ANDA	Current
58602-882	ACETAMINOPHEN ASPIRIN AND CAFFEINE	acetaminophen, aspirin and caffeine	Aurohealth LLC	ANDA	Current
58602-882	ACETAMINOPHEN ASPIRIN AND CAFFEINE	acetaminophen, aspirin and caffeine	Aurohealth LLC	ANDA	Current
58602-883	ACETAMINOPHEN ASPIRIN AND CAFFEINE	acetaminophen, aspirin and caffeine	Aurohealth LLC	ANDA	Current