Application 211544

Type: ANDA
Sponsor: GRANULES INDIA 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
A211544-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL			2019-04-16

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	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`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 3 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACETAMINOPHEN	ACETAMINOPHEN	Bryant Ranch Prepack	f6dc5576-9ba3-436c-87f5-8d0d6258adef	2024-10-07	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
TYLENOL 8 HR ARTHRITIS PAIN	ACETAMINOPHEN	Kenvue Brands LLC	0391963c-022d-1433-e063-6294a90aac90	2024-09-09	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 Hour Pain Relief	ACETAMINOPHEN	AMERISOURCE BERGEN	9ab903aa-7170-460b-9527-e3df223f5f55	2024-07-24	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 46122-630
ACETAMINOPHEN	ACETAMINOPHEN	GERI-CARE PHARMACEUTICAL CORP	92c22593-daf9-20a8-e053-2a95a90a365d	2024-07-23	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 57896-268
8 Hour Pain Relief	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	3ec966f5-bdcb-4bd8-b265-c776ba778f25	2024-06-13	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 Hour Arthritis Pain	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	b098ebf6-a76d-4550-b5c4-fdc3b4ceb9a8	2024-06-13	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8HR Muscle Aches and Pain	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	15abb899-e301-40e6-e063-6294a90a4bac	2024-06-13	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8HR Muscle Aches and Pain	ACETAMINOPHEN	FSA STORE INC.	13268603-0080-22cf-e063-6394a90a7db4	2024-06-13	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Pain Relief	PAIN RELIEF	Allegiant Health	f4720346-c3e0-4707-b007-1bf1f5e05707	2024-04-24	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 Hour Arthritis Pain	ACETAMINOPHEN	MARC GLASSMAN, INC.	e2387b9c-94c0-397a-e053-2995a90a444c	2023-11-02	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 68998-401
8 Hour Arthritis Pain	ACETAMINOPHEN	AMERISOURCE BERGEN	7888eff3-3030-4aa0-89e3-9795aa214659	2023-10-31	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 46122-629
DOLO - NeuroBion Acetaminophen Max Extended-Release 650 mg	ACETAMINOPHEN	BENARD INDUSTRIES INC	eaa9d094-ece6-41fd-97d9-0fdb0a45afd7	2023-06-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 Hour Pain Relief	ACETAMINOPHEN	STRATEGIC SOURCING SERVICES LLC	c003a34a-bfe5-4298-8a4e-8c75576f5674	2023-06-09	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
eight hour pain relief	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	b5fe8873-13c9-402e-b06c-6e679af7267e	2023-05-17	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 41163-203
HEB	ACETAMINOPHEN	HEB	96b1808f-defa-28cb-e053-2995a90a563b	2023-04-12	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 37808-120
Arthritis Pain Relief	ACETAMINOPHEN	WINCO FOODS, LLC	f45f43da-b994-2bc8-e053-2995a90a93e0	2023-04-11	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Arthritis Pain Relief	ACETAMINOPHEN	TOPCO ASSOCIATES LLC	e60aa992-f5f7-3506-e053-2995a90a7abd	2022-10-04	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 36800-632
Acetaminophen Extended-Release	ACETAMINOPHEN	Magno-Humphries, Inc.	9d22bedb-9fc9-8421-e053-2a95a90acf4a	2021-10-28	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 54257-573

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 93 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-9992	Acetaminophen	Acetaminophen	WALGREENS	ANDA	Current
0363-9992	Acetaminophen	Acetaminophen	WALGREENS	ANDA	Current
0363-9992	Acetaminophen	Acetaminophen	WALGREENS	ANDA	Current
0363-9992	Acetaminophen	Acetaminophen	WALGREENS	ANDA	Current
0363-9993	Acetaminophen	Acetaminophen	WALGREENS CO.	ANDA	Current
0363-9993	Acetaminophen	Acetaminophen	WALGREENS CO.	ANDA	Current
0363-9993	Acetaminophen	Acetaminophen	WALGREENS CO.	ANDA	Current
0363-9993	Acetaminophen	Acetaminophen	WALGREENS CO.	ANDA	Current
11822-5019	Acetaminophen	Acetaminophen	RITE AID	ANDA	Current
11822-5019	Acetaminophen	Acetaminophen	RITE AID	ANDA	Current
11822-5091	Acetaminophen	Acetaminophen	RITE AID	ANDA	Current
11822-6019	Muscle Pain Relief	Acetaminophen	Rite Aid Corporation	ANDA	Current
11822-6019	Muscle Pain Relief	Acetaminophen	Rite Aid Corporation	ANDA	Current
11822-6304	Acetaminophen	Acetaminophen	Rite Aid Corporation	ANDA	Current
11822-6304	Acetaminophen	Acetaminophen	Rite Aid Corporation	ANDA	Current
11822-6304	Acetaminophen	Acetaminophen	Rite Aid Corporation	ANDA	Current
11822-6304	Acetaminophen	Acetaminophen	Rite Aid Corporation	ANDA	Current
21130-124	Arthritis Pain	Acetaminophen	SAFEWAY	ANDA	Current
21130-124	Arthritis Pain	Acetaminophen	SAFEWAY	ANDA	Current
36800-632	Arthritis Pain Relief	Acetaminophen	TOPCO ASSOCIATES LLC	ANDA	Current
37808-120	HEB	Acetaminophen	HEB	ANDA	Current
41163-203	eight hour pain relief	Acetaminophen	UNFI	ANDA	Current
41250-658	arthritis pain relief	Acetaminophen	Meijer	ANDA	Current
46122-629	8 Hour Arthritis Pain	Acetaminophen	AMERISOURCE BERGEN	ANDA	Current
46122-629	8 Hour Arthritis Pain	Acetaminophen	AMERISOURCE BERGEN	ANDA	Current
46122-629	8 Hour Arthritis Pain	Acetaminophen	AMERISOURCE BERGEN	ANDA	Current
46122-630	8 Hour Pain Relief	Acetaminophen	AMERISOURCE BERGEN	ANDA	Current
46122-630	8 Hour Pain Relief	Acetaminophen	AMERISOURCE BERGEN	ANDA	Current
46122-630	8 Hour Pain Relief	Acetaminophen	AMERISOURCE BERGEN	ANDA	Current
46122-630	8 Hour Pain Relief	Acetaminophen	AMERISOURCE BERGEN	ANDA	Current
49035-181	Acetaminophen	Acetaminophen	WAL-MART STORES INC	ANDA	Current
49035-181	Acetaminophen	Acetaminophen	WAL-MART STORES INC	ANDA	Current
49035-181	Acetaminophen	Acetaminophen	WAL-MART STORES INC	ANDA	Current
50594-183	Acetaminophen	Acetaminophen	BIG LOTS STORES, INC.	ANDA	Current
50594-183	Acetaminophen	Acetaminophen	BIG LOTS STORES, INC.	ANDA	Current
53943-200	Arthritis Pain	Acetaminophen	DISCOUNT DRUG MART	ANDA	Current
54257-573	Acetaminophen Extended-Release	ACETAMINOPHEN	Magno-Humphries, Inc.	ANDA	Current
54257-573	Acetaminophen Extended-Release	ACETAMINOPHEN	Magno-Humphries, Inc.	ANDA	Current
54257-573	Acetaminophen Extended-Release	ACETAMINOPHEN	Magno-Humphries, Inc.	ANDA	Current
57896-268	ACETAMINOPHEN	ACETAMINOPHEN	GERI-CARE PHARMACEUTICAL CORP	ANDA	Current
59726-013	Arthritis Pain Reliever	Acetaminophen	P & L Development, LLC	ANDA	Current
62207-183	ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	ANDA	Current
62207-183	ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	ANDA	Current
62207-183	ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	ANDA	Current
62207-183	ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	ANDA	Current
62207-183	ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	ANDA	Current
62207-183	ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	ANDA	Current
62207-183	ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	ANDA	Current
62207-188	ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	ANDA	Current
62207-188	ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	ANDA	Current
62207-188	ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	ANDA	Current
62207-188	ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	ANDA	Current
62207-188	ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	ANDA	Current
62207-188	ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	ANDA	Current
62207-188	ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	ANDA	Current
63868-412	Acetaminophen	Acetaminophen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-412	Acetaminophen	Acetaminophen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-413	Acetaminophen	Acetaminophen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-413	Acetaminophen	Acetaminophen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-591	Acetaminophen	Acetaminophen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-591	Acetaminophen	Acetaminophen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-660	Acetaminophen	Acetaminophen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-660	Acetaminophen	Acetaminophen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63868-679	8 Hour Pain Relief	Acetaminophen	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA	Current
63941-300	8 Hour Arthritis Pain	Acetaminophen	VALU MERCHANDISERS COMPANY	ANDA	Current
63941-401	8 Hour Pain Relief	Acetaminophen	VALU MERCHANDISERS COMPANY	ANDA	Current
68016-183	Acetaminophen	Acetaminophen	PHARMACY VALUE ALLIANCE, LLC	ANDA	Current
68016-183	Acetaminophen	Acetaminophen	PHARMACY VALUE ALLIANCE, LLC	ANDA	Current
68016-303	Arthritis Pain Relief	Acetaminophen	CHAIN DRUG CONSORTIUM	ANDA	Current
68196-935	Acetaminophen	Acetaminophen	SAM'S WEST INC	ANDA	Current
68998-300	Arthritis Pain	Acetaminophen	MARC GLASSMAN, INC.	ANDA	Current
68998-401	8 Hour Arthritis Pain	Acetaminophen	MARC GLASSMAN, INC.	ANDA	Current
69842-297	Acetaminophen	Acetaminophen	CVS PHARMACY iNC	ANDA	Current
69842-297	Acetaminophen	Acetaminophen	CVS PHARMACY iNC	ANDA	Current
69842-297	Acetaminophen	Acetaminophen	CVS PHARMACY iNC	ANDA	Current
69842-322	Acetaminophen	Acetaminophen	CVS PHARMACY INC	ANDA	Current
69848-015	Acetaminophen	Acetaminophen	Granules USA, Inc.	ANDA	Current
69848-015	Acetaminophen	Acetaminophen	Granules USA, Inc.	ANDA	Current
69848-015	Acetaminophen	Acetaminophen	Granules USA, Inc.	ANDA	Current
70010-160	ACETAMINOPHEN	ACETAMINOPHEN	Granules Pharmaceuticals Inc.	ANDA	Current