Application 078569

Type: ANDA
Sponsor: SUN PHARM INDS LTD

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 42.

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
A078569-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL			2011-12-14

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078569-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-14	`e64feba35796…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	CVS Pharmacy	6f880abe-5284-42b0-9db6-b071444b197b	2024-12-27	Warnings	Exact identifier application applno (ANDA): 078569 application number: ANDA078569 ndc (product): 69842-930
Acetaminophen	ACETAMINOPHEN	Walgreen Company	a1cec332-5802-4684-8b7f-6cb98da40e8b	2018-08-15	Warnings	Exact identifier application applno (ANDA): 078569 application number: ANDA078569 ndc (product): 0363-0340

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0340	Acetaminophen	Acetaminophen	Walgreen Company	ANDA	Current
37205-662	Acetaminophen	Acetaminophen	Cardinal Health	ANDA	Current
49035-350	Acetaminophen	Acetaminophen	Wal-Mart Stores, Inc	ANDA	Current
51660-340	Acetaminophen	Acetaminophen	Ohm Laboratories Inc.	ANDA	Current
59779-340	ARTHRITIS PAIN RELIEF	Acetaminophen	CVS PHARMACY	ANDA	Current
59779-340	ARTHRITIS PAIN RELIEF	Acetaminophen	CVS PHARMACY	ANDA	Current
68016-340	Premier Value Arthritis Pain Reliever	Acetaminophen	Chain Drug Consortium, LLC	ANDA	Current
69842-930	Acetaminophen	Acetaminophen	CVS Pharmacy	ANDA	Current
69842-930	Acetaminophen	Acetaminophen	CVS Pharmacy	ANDA	Current