Application 207035

Type: ANDA
Sponsor: HERITAGE PHARMA

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
A207035-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL			2018-05-31

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	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`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 33 of 49 · 961 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
foster and thrive pain reliever	ACETAMINOPHEN	Strategic Sourcing Services LLC	338021bd-b92b-45eb-a4b8-bc4a100ab718	2024-11-06	Warnings	Name fallback generic name: ACETAMINOPHEN
DOLO- NeuroBion Acetaminophen 500mg	ACETAMINOPHEN	BENARD INDUSTRIES INC	16f8415d-8190-4212-b487-c0caf7d3bee2	2024-11-04	Warnings	Name fallback generic name: ACETAMINOPHEN
basic care acetaminophen	ACETAMINOPHEN	Amazon.com Services LLC	8c3343ee-d7b6-496d-9702-6736539a7270	2024-11-02	Warnings	Name fallback generic name: ACETAMINOPHEN
dg health pain relief	ACETAMINOPHEN	Dolgencorp, LLC	382fa2cc-1c39-4bee-b528-08b11ec945af	2024-11-02	Warnings	Name fallback generic name: ACETAMINOPHEN
acetaminophen	ACETAMINOPHEN	Bryant Ranch Prepack	f7e20527-1d4b-434c-997b-3eb8211fdaa1	2024-11-01	Warnings	Name fallback brand name: acetaminophen generic name: ACETAMINOPHEN
acetaminophen	ACETAMINOPHEN	Bryant Ranch Prepack	614e69c7-d3cb-4d47-9603-c1c14b87544c	2024-11-01	Warnings	Name fallback brand name: acetaminophen generic name: ACETAMINOPHEN
infants fever reducer and pain reliever	ACETAMINOPHEN	Rite Aid Corporation	baee03b8-fcfd-440e-90ea-1ee2a18516ef	2024-11-01	Warnings	Name fallback generic name: ACETAMINOPHEN
good neighbor pharmacy infants pain and fever	ACETAMINOPHEN	Amerisource Bergen	bfb954b7-3a79-4bca-95e8-d39e1074b07f	2024-11-01	Warnings	Name fallback generic name: ACETAMINOPHEN
Infants Pain Relief	ACETAMINOPHEN	Publix Super Markets Inc	0bc33897-afc2-4d11-be6c-a26480f448bf	2024-10-31	Warnings	Name fallback generic name: ACETAMINOPHEN
equate infants pain and fever	ACETAMINOPHEN	WALMART INC.	34b2512e-743b-45db-92cb-ea05e2f47b3d	2024-10-31	Warnings	Name fallback generic name: ACETAMINOPHEN
foster and thrive infants pain and fever	ACETAMINOPHEN	Strategic Sourcing Services LLC	45770ad6-9bf7-41bd-a724-e5260cd31fa1	2024-10-31	Warnings	Name fallback generic name: ACETAMINOPHEN
up and up infants acetaminophen	ACETAMINOPHEN	Target Corporation	31104956-04d7-41b5-82be-219ded5c02a9	2024-10-30	Warnings	Name fallback generic name: ACETAMINOPHEN
Good Neighbor Pharmacy Pain Relief	ACETAMINOPHEN	Amerisource Bergen	5101125d-4819-4e4b-a0ee-a0ff8d5a0ab1	2024-10-30	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	PAIN RELIEVER	McKesson	9d620700-5d00-475f-e053-2995a90a9a3f	2024-10-28	Warnings	Name fallback brand name: Acetaminophen
Junior Acetaminophen Ages 6-11	ACETAMINOPHEN	Chain Drug Consortium	d356bc9c-66f1-45c3-a455-98c0b8890f78	2024-10-28	Warnings	Name fallback generic name: ACETAMINOPHEN
leader Acetaminophen	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	36bdcac9-eed4-40f9-a6f2-4c1e773a6b50	2024-10-25	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Kroger Company	5bfd9841-c781-43be-b823-d334893ae6ed	2024-10-24	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Pain Relief	ACETAMINOPHEN	H E B	add6952e-9dd5-487c-93e6-337e9d6a4872	2024-10-24	Warnings	Name fallback generic name: ACETAMINOPHEN
Dye Free Pain Reliever Childrens	ACETAMINOPHEN	Safeway, Inc.	7d55cb42-295f-473a-941d-71825b44a3c0	2024-10-24	Warnings	Name fallback generic name: ACETAMINOPHEN
rapid release pain relief	ACETAMINOPHEN	Publix Super Markets Inc	d0b34133-d69d-47db-bf51-be942769c612	2024-10-24	Warnings	Name fallback generic name: ACETAMINOPHEN

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 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11822-6690	Acetaminophen	Acetaminophen	Rite Aid Corporation	ANDA	Current
11822-6690	Acetaminophen	Acetaminophen	Rite Aid Corporation	ANDA	Current
23155-202	Acetamiophen	Acetaminophen	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-202	Acetamiophen	Acetaminophen	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-202	Acetamiophen	Acetaminophen	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-202	Acetamiophen	Acetaminophen	Heritage Pharmaceuticals Inc.	ANDA	Current
41163-669	Acetaminophen	Acetaminophen	EQUALINE (SuperValu)	ANDA	Current
41163-669	Acetaminophen	Acetaminophen	EQUALINE (SuperValu)	ANDA	Current
41163-669	Acetaminophen	Acetaminophen	EQUALINE (SuperValu)	ANDA	Current
41163-669	Acetaminophen	Acetaminophen	EQUALINE (SuperValu)	ANDA	Current
41163-669	Acetaminophen	Acetaminophen	EQUALINE (SuperValu)	ANDA	Current
59726-669	ArthritisPain Relief	Acetaminophen	P & L Development, LLC	ANDA	Current
59726-669	ArthritisPain Relief	Acetaminophen	P & L Development, LLC	ANDA	Current
59726-671	Muscle Pain Relief	Acetaminophen	P & L Development, LLC	ANDA	Current
69842-093	Acetaminophen	Acetaminophen	CVS Pharmacy	ANDA	Current
69842-093	Acetaminophen	Acetaminophen	CVS Pharmacy	ANDA	Current
69842-093	Acetaminophen	Acetaminophen	CVS Pharmacy	ANDA	Current
69842-093	Acetaminophen	Acetaminophen	CVS Pharmacy	ANDA	Current