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 1 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8HR Arthritis Pain	ACETAMINOPHEN	HARRIS TEETER	bfee9b3e-0c50-7c10-e053-2995a90af2fe	2026-08-05	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
8 HR Arthritis Pain	ACETAMINOPHEN	Dr. Reddy's Laboratories Inc.	8e780c23-997c-b960-226e-954037baad4b	2026-07-01	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
ACETAMINOPHEN	ACETAMINOPHEN	Granules India Limited	00eb3e4b-1507-4c9a-83a5-ef50cb312753	2026-06-15	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 62207-188 ndc (product): 62207-183
Arthritis Pain	ACETAMINOPHEN	Grocery Outlet, Inc.	441d0aa0-9a65-98e9-e063-6294a90a5eb2	2026-05-21	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
ACETAMINOPHEN	ACETAMINOPHEN	NCS HealthCare of KY, LLC dba Vangard Labs	a3217b48-7482-4cc7-8811-ae75fd9d7805	2026-02-26	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	CVS PHARMACY INC	bd8ce39f-ccf8-3976-e053-2a95a90abb1f	2025-12-23	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 69842-322
Acetaminophen	ACETAMINOPHEN	Granules USA, Inc.	96131c7b-bdff-0642-e053-2a95a90a4f32	2025-12-22	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 69848-015
Acetaminophen	ACETAMINOPHEN	WAL-MART STORES INC	940936ac-e59f-7489-e053-2a95a90a6364	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 49035-181
Acetaminophen	ACETAMINOPHEN	WAL-MART STORES INC	e34d07b5-ccbb-cd14-e053-2a95a90a394b	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	MEIJER DISTRIBUTION INC	ed23c587-7806-1f64-e053-2a95a90aea7f	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	MEIJER, INC.	ed25620f-e39b-e30c-e053-2995a90af621	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES,LLC.	a0fb0afe-9c25-d0f6-e053-2995a90adbba	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES,LLC.	a56791ec-0037-51a3-e053-2995a90af761	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	WALGREENS	8f8d43d1-8e73-483e-e053-2a95a90ac99b	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 0363-9992
Acetaminophen	ACETAMINOPHEN	WALGREENS CO.	8dba6ae0-1bfb-84de-e053-2a95a90aae46	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 0363-9993
Acetaminophen	ACETAMINOPHEN	LEADER/ Cardinal Health 110, Inc	f797848e-f23f-997b-e053-6394a90aae55	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	MAJOR PHARMACEUTICALS	efd0a432-abbb-1f88-e053-2995a90a8ce5	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	LEADER/ Cardinal Health 110, Inc	f5dc335d-d3cf-ba94-e053-2a95a90ac6d3	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
Acetaminophen	ACETAMINOPHEN	SAM'S WEST INC	e77c2bc7-0258-4a6d-e053-2a95a90afe6e	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 68196-935
Acetaminophen	ACETAMINOPHEN	CVS PHARMACY iNC	90cea23f-5ddb-7a36-e053-2a95a90a20cf	2025-12-19	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544 ndc (product): 69842-297

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