Application 075077

Type: ANDA
Sponsor: PERRIGO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN	ACETAMINOPHEN	TABLET, EXTENDED RELEASE;ORAL	650MG	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
A075077-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL			2000-02-25

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075077-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2000-02-25	`f41ea6bd6efb…`

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 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
arthritis pain relief	ACETAMINOPHEN	Publix Super Markets Inc	af407852-5476-421d-a80a-d726c24b6391	2025-05-09	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
arthritis pain reliever	ACETAMINOPHEN	Walgreen Company	5028c116-d0e3-4e30-8fa8-caaf08d99ec7	2025-05-09	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077 ndc (product): 0363-0544
Pain Relief 8 HR	ACETAMINOPHEN	H E B	b5c7e93b-e626-49c3-a7d4-773475f945ae	2022-11-12	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077 ndc (product): 37808-747
arthritis pain relief	ACETAMINOPHEN	Meijer Distribution Inc	c388f3a5-03bb-4fed-b81a-bb876bc260f0	2022-10-27	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
Pain Relief	ACETAMINOPHEN	Meijer Distribution Inc	bfe37210-b322-4edb-8ff2-aff9b3e66be0	2022-10-27	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
Equate 8HR Arthritis Pain Relief	ACETAMINOPHEN	Wal-Mart Stores Inc	ca7f0f68-2862-4265-bf4a-3a89994b4d6b	2022-10-13	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077
topcare 8 hr arthritis pain relief	ACETAMINOPHEN	Topco Associates LLC	0d427360-ff9d-4e98-b218-6eb6c015dc6a	2022-05-23	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077 ndc (product): 36800-779
basic care acetaminophen	ACETAMINOPHEN	Amazon.com Services LLC	b0c55ac4-0b1a-4411-9df3-6bb64e20ea22	2022-03-23	Warnings	Exact identifier application applno (ANDA): 075077 application number: ANDA075077

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 1 of 3 · 174 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0044	Good Sense Pain Relief	Acetaminophen	L. Perrigo Company	ANDA	Current
0113-0044	Good Sense Pain Relief	Acetaminophen	L. Perrigo Company	ANDA	Current
0113-0044	Good Sense Pain Relief	Acetaminophen	L. Perrigo Company	ANDA	Current
0113-0217	good sense pain relief	Acetaminophen	L. Perrigo Company	ANDA	Current
0113-0217	good sense pain relief	Acetaminophen	L. Perrigo Company	ANDA	Current
0113-0544	good sense pain relief	Acetaminophen	L. Perrigo Company	ANDA	Current
0113-0544	good sense pain relief	Acetaminophen	L. Perrigo Company	ANDA	Current
0113-0544	good sense pain relief	Acetaminophen	L. Perrigo Company	ANDA	Current
0113-7544	Basic Care Acetaminophen	Acetaminophen	L. Perrigo Company	ANDA	Current
0113-7544	Basic Care Acetaminophen	Acetaminophen	L. Perrigo Company	ANDA	Current
0113-7544	Basic Care Acetaminophen	Acetaminophen	L. Perrigo Company	ANDA	Current
0280-8090	Midol Long Lasting Relief	Acetaminophen	Bayer HealthCare LLC.	ANDA	Current
0280-8090	Midol Long Lasting Relief	Acetaminophen	Bayer HealthCare LLC.	ANDA	Current
0280-8090	Midol Long Lasting Relief	Acetaminophen	Bayer HealthCare LLC.	ANDA	Current
0280-8090	Midol Long Lasting Relief	Acetaminophen	Bayer HealthCare LLC.	ANDA	Current
0280-8090	Midol Long Lasting Relief	Acetaminophen	Bayer HealthCare LLC.	ANDA	Current
0363-0544	arthritis pain reliever	Acetaminophen	Walgreen Company	ANDA	Current
0363-0544	arthritis pain reliever	Acetaminophen	Walgreen Company	ANDA	Current
0363-0544	arthritis pain reliever	Acetaminophen	Walgreen Company	ANDA	Current
0615-7590	Acetaminophen Extended Release	Acetaminophen	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7590	Acetaminophen Extended Release	Acetaminophen	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-7590	Acetaminophen Extended Release	Acetaminophen	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-5769	mapap arthritis pain	Acetaminophen	Major Pharmaceuticals	ANDA	Current
0904-5769	mapap arthritis pain	Acetaminophen	Major Pharmaceuticals	ANDA	Current
0904-5769	mapap arthritis pain	Acetaminophen	Major Pharmaceuticals	ANDA	Current
0904-6883	major acetaminophen	Acetaminophen	Major Pharmaceuticals	ANDA	Current
0904-6883	major acetaminophen	Acetaminophen	Major Pharmaceuticals	ANDA	Current
0904-6883	major acetaminophen	Acetaminophen	Major Pharmaceuticals	ANDA	Current
11673-210	Up and Up Arthritis Pain Relief	Acetaminophen	Target Corporation	ANDA	Current
11673-210	Up and Up Arthritis Pain Relief	Acetaminophen	Target Corporation	ANDA	Current
11673-544	up and up temporary minor arthritis pain relief	Acetaminophen	Target Corporation	ANDA	Current
11673-618	Up and Up acetaminophen	Acetaminophen	Target Corporation	ANDA	Current
11673-618	Up and Up acetaminophen	Acetaminophen	Target Corporation	ANDA	Current
11673-966	up and up acetaminophen	Acetaminophen	Target Corporation	ANDA	Current
11673-966	up and up acetaminophen	Acetaminophen	Target Corporation	ANDA	Current
11822-0217	acetaminophen	Acetaminophen	Rite Aid Corporation	ANDA	Current
11822-0217	acetaminophen	Acetaminophen	Rite Aid Corporation	ANDA	Current
11822-0544	Acetaminophen	Acetaminophen	Rite Aid Corporation	ANDA	Current
11822-0631	Acetaminophen	Acetaminophen	Rite Aid Corporation	ANDA	Current
11822-0631	Acetaminophen	Acetaminophen	Rite Aid Corporation	ANDA	Current
24385-629	good neighbor pharmacy pain relief	Acetaminophen	Amerisource Bergen	ANDA	Current
24385-629	good neighbor pharmacy pain relief	Acetaminophen	Amerisource Bergen	ANDA	Current
30142-119	Acetaminophen	Acetaminophen	Kroger Company	ANDA	Current
30142-119	Acetaminophen	Acetaminophen	Kroger Company	ANDA	Current
30142-313	acetaminophen	Acetaminophen	Kroger Company	ANDA	Current
30142-544	arthritis pain relief	Acetaminophen	Kroger Company	ANDA	Current
30142-544	arthritis pain relief	Acetaminophen	Kroger Company	ANDA	Current
30142-789	arthritis pain	acetaminophen	Kroger Company	ANDA	Current
30142-789	arthritis pain	acetaminophen	Kroger Company	ANDA	Current
30142-792	arthritis pain	acetaminophen	Kroger Company	ANDA	Current
30142-966	arthritis pain relief	Acetaminophen	Kroger Company	ANDA	Current
30142-966	arthritis pain relief	Acetaminophen	Kroger Company	ANDA	Current
30142-966	arthritis pain relief	Acetaminophen	Kroger Company	ANDA	Current
36800-369	Topcare 8 Hour Pain Relief	Acetaminophen	Topco Associates LLC	ANDA	Current
36800-369	Topcare 8 Hour Pain Relief	Acetaminophen	Topco Associates LLC	ANDA	Current
36800-369	Topcare 8 Hour Pain Relief	Acetaminophen	Topco Associates LLC	ANDA	Current
36800-369	Topcare 8 Hour Pain Relief	Acetaminophen	Topco Associates LLC	ANDA	Current
36800-369	Topcare 8 Hour Pain Relief	Acetaminophen	Topco Associates LLC	ANDA	Current
36800-404	topcare arthritis pain	Acetaminophen	Topco Associates LLC	ANDA	Current
36800-404	topcare arthritis pain	Acetaminophen	Topco Associates LLC	ANDA	Current
36800-455	topcare 8 hr arthritis pain relief	Acetaminophen	Topco Associates LLC	ANDA	Current
36800-455	topcare 8 hr arthritis pain relief	Acetaminophen	Topco Associates LLC	ANDA	Current
36800-455	topcare 8 hr arthritis pain relief	Acetaminophen	Topco Associates LLC	ANDA	Current
36800-544	Topcare Arthritis Pain Relief	Acetaminophen	Topco Associates LLC	ANDA	Current
36800-779	topcare 8 hr arthritis pain relief	Acetaminophen	Topco Associates LLC	ANDA	Current
36800-779	topcare 8 hr arthritis pain relief	Acetaminophen	Topco Associates LLC	ANDA	Current
36800-779	topcare 8 hr arthritis pain relief	Acetaminophen	Topco Associates LLC	ANDA	Current
37012-544	Arthritis Pain	Acetaminophen	Shopko Stores Operating Co., LLC	ANDA	Current
37012-544	Arthritis Pain	Acetaminophen	Shopko Stores Operating Co., LLC	ANDA	Current
37808-455	Pain Relief	Acetaminophen	H E B	ANDA	Current
37808-455	Pain Relief	Acetaminophen	H E B	ANDA	Current
37808-747	Pain Relief 8 HR	Acetaminophen	H E B	ANDA	Current
37808-747	Pain Relief 8 HR	Acetaminophen	H E B	ANDA	Current
37808-747	Pain Relief 8 HR	Acetaminophen	H E B	ANDA	Current
41163-544	equaline arthritis	Acetaminophen	Supervalu Inc	ANDA	Current
41190-544	ShopRite Arthritis Pain	Acetaminophen	Wakefern Food Corporation	ANDA	Current
41250-544	arthritis pain relief	Acetaminophen	Meijer Distribution Inc	ANDA	Current
41250-544	arthritis pain relief	Acetaminophen	Meijer Distribution Inc	ANDA	Current
41250-544	arthritis pain relief	Acetaminophen	Meijer Distribution Inc	ANDA	Current
41250-544	arthritis pain relief	Acetaminophen	Meijer Distribution Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22414	ORIG	2001-06-07
30750	ORIG	2000-02-25