Application 207229

Type: ANDA
Sponsor: AUROBINDO PHARMA 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 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
A207229-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL			2016-11-09

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	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207229-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2016-11-09	`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 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Aurohealth LLC	e072e4ab-669d-40ee-b301-0bc15b67792f	2026-05-21	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229 ndc (product): 58602-848
Acetaminophen	ACETAMINOPHEN	Better Living Brands, LLC	de3d9840-4ada-5c9a-e053-2a95a90a5721	2026-04-21	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229 ndc (product): 21130-108
Acetaminophen	ACETAMINOPHEN	American Health Packaging	88e5345a-f240-473c-b329-2b0aa5f081f9	2026-02-04	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229
Acetaminophen	ACETAMINOPHEN	KROGER COMPANY	b9b63c38-83e7-62d2-e053-2a95a90a5526	2024-10-19	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229 ndc (product): 30142-157
Acetaminophen	ACETAMINOPHEN	BluePoint Laboratories	c065c531-88f5-0930-e053-2a95a90ae861	2024-06-05	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229 ndc (product): 68001-495
AMAZON BASIC CARE ACETAMINOPHEN	ACETAMINOPHEN	Amazon.com Services LLC	113df1bc-a217-33ea-e063-6294a90a4643	2024-05-14	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229
Acetaminophen	ACETAMINOPHEN	WALGREEN CO.	c20d110a-ed5e-aed4-e053-2a95a90a4200	2024-05-06	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229 ndc (product): 0363-9604
Acetaminophen	ACETAMINOPHEN	Aurohealth LLC	f076fd33-9eaf-49b9-b0ee-6a349567c5ff	2024-01-24	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229 ndc (product): 58602-873
Acetaminophen	ACETAMINOPHEN	CVS Pharmacy, Inc.	b70beee4-407e-547c-e053-2a95a90af22a	2024-01-24	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229 ndc (product): 69842-037
Acetaminophen	ACETAMINOPHEN	Aurohealth LLC	179c221d-c099-400c-b3ac-124e26947620	2024-01-24	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229 ndc (product): 58602-730
Acetaminophen	ACETAMINOPHEN	CVS Pharmacy, Inc.	e577fdf0-85b1-1471-e053-2995a90a6fcd	2024-01-24	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229 ndc (product): 69842-635
Acetaminophen	ACETAMINOPHEN	WALMART INC.	0035a4fd-8dd5-4534-a1b5-f510d637f721	2024-01-24	Warnings	Exact identifier application applno (ANDA): 207229 application number: ANDA207229 ndc (product): 79903-132

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-9604	Acetaminophen	Acetaminophen	WALGREEN CO.	ANDA	Current
0363-9604	Acetaminophen	Acetaminophen	WALGREEN CO.	ANDA	Current
0363-9604	Acetaminophen	Acetaminophen	WALGREEN CO.	ANDA	Current
21130-108	Acetaminophen	Acetaminophen	Better Living Brands, LLC	ANDA	Current
30142-157	Acetaminophen	Acetaminophen	KROGER COMPANY	ANDA	Current
30142-157	Acetaminophen	Acetaminophen	KROGER COMPANY	ANDA	Current
58602-730	Acetaminophen	Acetaminophen	Aurohealth LLC	ANDA	Current
58602-730	Acetaminophen	Acetaminophen	Aurohealth LLC	ANDA	Current
58602-730	Acetaminophen	Acetaminophen	Aurohealth LLC	ANDA	Current
58602-730	Acetaminophen	Acetaminophen	Aurohealth LLC	ANDA	Current
58602-730	Acetaminophen	Acetaminophen	Aurohealth LLC	ANDA	Current
58602-730	Acetaminophen	Acetaminophen	Aurohealth LLC	ANDA	Current
58602-848	Acetaminophen	Acetaminophen	Aurohealth LLC	ANDA	Current
58602-848	Acetaminophen	Acetaminophen	Aurohealth LLC	ANDA	Current
58602-848	Acetaminophen	Acetaminophen	Aurohealth LLC	ANDA	Current
58602-866	Acetaminophen	Acetaminophen	Aurohealth LLC	ANDA	Current
58602-873	Acetaminophen	Acetaminophen	Aurohealth LLC	ANDA	Current
68001-495	Acetaminophen	Acetaminophen	BluePoint Laboratories	ANDA	Current
69842-037	Acetaminophen	Acetaminophen	CVS Pharmacy, Inc.	ANDA	Current
69842-037	Acetaminophen	Acetaminophen	CVS Pharmacy, Inc.	ANDA	Current
69842-037	Acetaminophen	Acetaminophen	CVS Pharmacy, Inc.	ANDA	Current
69842-635	Acetaminophen	Acetaminophen	CVS Pharmacy, Inc.	ANDA	Current
79903-132	Acetaminophen	Acetaminophen	WALMART INC.	ANDA	Current