Application 075794

Type: ANDA
Sponsor: PERRIGO

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 44.

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
A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	ACETAMINOPHEN; ASPIRIN; CAFFEINE	250MG;250MG;65MG	TABLET / ORAL			2001-11-26

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075794-001	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	250MG;250MG;65MG	TABLET / ORAL	2001-11-26	`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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
basic care migraine relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Amazon.com Services LLC	edcc7b4b-1317-4060-b947-8c16effc5742	2023-02-27	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794 ndc (product): 72288-374
basic care migraine relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Amazon.com Services LLC	a19798b3-1b2e-4e4f-b595-2a156bd52ee5	2022-07-28	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794 ndc (product): 72288-295
topcare migraine relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Topco Associates LLC	9163ecfe-6493-46eb-a08d-b4134d84b0ab	2022-06-28	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794
dg health migraine relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Dolgencorp Inc	673d42d8-b484-4232-bc91-19d83db63550	2022-06-07	Warnings	Exact identifier application applno (ANDA): 075794 application number: ANDA075794

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 90 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70000-0247	Leader Migraine Relief	Acetaminophen, Aspirin, Caffeine	Cardinal Health	ANDA	Current
70000-0611	leader migraine relief	acetaminophen, aspirin, caffeine	Cardinal Health 110, LLC. dba Leader	ANDA	Current
70518-0321	Leader migraine formula	Acetaminophen, Aspirin, Caffeine	REMEDYREPACK INC.	ANDA	Current
70677-0119	sunmark migraine relief	Acetaminophen, Aspirin, Caffeine	Strategic Sourcing Services LLC	ANDA	Current
70677-0119	sunmark migraine relief	Acetaminophen, Aspirin, Caffeine	Strategic Sourcing Services LLC	ANDA	Current
71713-101	Cove Migraine Relief	Acetaminophen, Aspirin, Caffeine	THIRTY MADISON INC	ANDA	Current
71713-101	Cove Migraine Relief	Acetaminophen, Aspirin, Caffeine	THIRTY MADISON INC	ANDA	Current
72288-295	basic care migraine relief	acetaminophen, aspirin, caffeine	Amazon.com Services LLC	ANDA	Current
72288-374	basic care migraine relief	Acetaminophen, Aspirin, Caffeine	Amazon.com Services LLC	ANDA	Current
81522-374	caring mill migraine relief	Acetaminophen, Aspirin, Caffeine	FSA Store Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8792	ORIG	2003-04-15