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 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
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 · 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	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`84e616aacf4f…`
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…`

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 2 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Walgreens	0944a5d4-2ccc-5f0d-e063-6394a90a8af9	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	RITE AID	d20b4682-fed2-3ea2-e053-2995a90aa47e	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 11822-5019
Acetaminophen	ACETAMINOPHEN	FAMILY DOLLAR	f824602a-8e7b-b8c3-e053-6294a90a6d9d	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	RITE AID	d20a7f7a-febf-54f9-e053-2a95a90a06b1	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 11822-5091
8 Hour Arthritis Pain	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	cd3a7094-ddb5-4583-a1bc-dc6ce280418c	2025-12-11	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 63941-300
8 Hour Pain Relief	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	d11a7412-a543-0e34-e053-2995a90afd63	2025-12-11	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 63941-401
Acetaminophen	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	2e30754a-42f7-4da2-944c-be61cee47b43	2025-12-10	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 63868-660
ACETAMINOPHEN	ACETAMINOPHEN	Granules Pharmaceuticals Inc.	d5352861-6926-f1b0-e053-2a95a90a7d66	2025-12-04	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 70010-160
Arthritis Pain	ACETAMINOPHEN	AMERIFOODS TRADING COMPANY	3802bc07-3154-f36a-e063-6294a90ac1cc	2025-11-20	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Pain Relief	ACETAMINOPHEN	HYVEE INC	42394377-c874-a955-e063-6294a90ace0b	2025-11-20	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Arthritis Pain	ACETAMINOPHEN	HYVEE INC	3e61b583-c1cb-23bd-e063-6294a90aa006	2025-11-20	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Arthritis Pain	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	3e9b237c-5df4-9ec5-e063-6394a90a87de	2025-09-12	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Arthritis Pain	ACETAMINOPHEN	DISCOUNT DRUG MART	973bcf75-8c45-ea16-e053-2a95a90aad63	2025-06-30	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 53943-200
8HR Arthritis Pain	ACETAMINOPHEN	FSA STORE INC.	06446e9a-0e83-0623-e063-6294a90ac403	2025-03-07	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
ACETAMINOPHEN	ACETAMINOPHEN	Bi-Mart	ab2f0834-bdef-4862-b549-5a8161f8420b	2025-03-01	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	RITE AID	d1f18c32-c043-7c97-e053-2a95a90a203e	2025-01-16	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 11822-5019
TYLENOL 8 HR MUSCLE ACHES AND PAIN	ACETAMINOPHEN	Kenvue Brands LLC	037ec598-cba6-dbb6-e063-6394a90ac42c	2024-11-07	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Arthritis Pain Relief	ACETAMINOPHEN	CHAIN DRUG CONSORTIUM	778a15d5-3fa4-4386-8afb-751f4537c10d	2024-10-11	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 68016-303
arthritis pain relief	ACETAMINOPHEN	Meijer	9f03fdb0-7dc0-376e-e053-2995a90ace05	2024-10-11	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 41250-658
8 Hour Pain Relief	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	1da0bd23-9f26-4913-9ebf-1fd8b0fb3bd3	2024-10-11	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 63868-679

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 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