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 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
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 · 41 observed 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	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…`
2022-09-29 23:25 UTC	2022-09	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207035-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2018-05-31	`cb3db0bc1861…`

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 51 · 1,011 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACETAMINOPHEN	ACETAMINOPHEN	Kroger Company	bc17b2e5-4828-6a2e-e053-2995a90a8c63	2026-08-05	Warnings	Name fallback brand name: ACETAMINOPHEN generic name: ACETAMINOPHEN
Infants TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	997b9551-c222-4a9c-8ba1-09a5f97495fa	2026-08-05	Warnings	Name fallback generic name: ACETAMINOPHEN
Mantra Pain Gel raspberry	ACETAMINOPHEN	MOREMED INC.	7c8bdf49-a6d2-4e42-b006-375f103fd0ac	2026-08-05	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	HARRIS TEETER	d2d2846d-4e0b-4d42-b300-60dd3b2cca1b	2026-08-05	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	HARRIS TEETER	960f5676-d8c5-470b-a663-4b8d152339b4	2026-08-05	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	HARRIS TEETER	a60f6439-2033-4bd2-b78c-6c083414a12b	2026-08-05	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Harris Teeter	50e7b939-e0eb-44ea-82ea-034e844e2c29	2026-08-05	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
8HR Arthritis Pain	ACETAMINOPHEN	HARRIS TEETER	bfee9b3e-0c50-7c10-e053-2995a90af2fe	2026-08-05	Warnings	Name fallback generic name: ACETAMINOPHEN
childrens acetaminophen	ACETAMINOPHEN	WinCo Foods, LLC	4749a843-9c93-4edd-9b5f-a1e32666544e	2026-08-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Reliever	ACETAMINOPHEN	Better Living Brands, LLC	743af02c-c762-42f5-8e01-2f62da15e04e	2026-08-04	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	9aea8aae-8702-4c93-8b07-69cd252f44d6	2026-08-03	Warnings	Name fallback generic name: ACETAMINOPHEN
Pain Relief Acetaminophen 325 mg	ACETAMINOPHEN	NUVICARE LLC	49a59b79-b8b4-4bf5-a403-0a14751efc55	2026-08-03	Warnings	Name fallback generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	d4e98f8e-f24c-4bdd-b750-fa4f877fb621	2026-07-31	Warnings	Name fallback generic name: ACETAMINOPHEN
KinderFarms Childrens Pain and Fever	ACETAMINOPHEN	KinderFarms, LLC	4f86419a-b940-a9c6-e063-6394a90a6a2b	2026-07-30	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen Extra Strength	ACETAMINOPHEN	Family Dollar Stores, LLC	53f7a9c8-f40e-19b2-e063-6394a90a8695	2026-07-29	Warnings	Name fallback generic name: ACETAMINOPHEN
KinderFarms Infants Pain and Fever	ACETAMINOPHEN	KinderFarms, LLC	5468b149-8fac-8d6a-e063-6294a90a8c51	2026-07-29	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	CVS PHARMACY	258975d2-d8e8-407d-9804-df3b37a184e4	2026-07-29	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	f818996c-36d2-4d3d-af3e-39949157edb9	2026-07-28	Warnings	Name fallback generic name: ACETAMINOPHEN
Infants TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	2143cc16-86db-4060-96da-5c228ae9207b	2026-07-24	Warnings	Name fallback generic name: ACETAMINOPHEN
Acetaminophen	ACETAMINOPHEN	Softgel Healthcare Pvt Ltd	352bb451-ffdc-411a-e063-6294a90a8cf5	2026-07-24	Warnings	Name fallback brand name: Acetaminophen generic name: ACETAMINOPHEN

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