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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A211544-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2019-04-16	`c2088c7a36db…`
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…`

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 · 55 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACETAMINOPHEN	ACETAMINOPHEN	GERI-CARE PHARMACEUTICAL CORP	92c22593-daf9-20a8-e053-2a95a90a365d	2024-07-23	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
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
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
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
HEB	ACETAMINOPHEN	HEB	96b1808f-defa-28cb-e053-2995a90a563b	2023-04-12	Warnings	Exact identifier application applno (ANDA): 211544 application number: ANDA211544
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
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

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 2 of 2 · 93 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70010-160	ACETAMINOPHEN	ACETAMINOPHEN	Granules Pharmaceuticals Inc.	ANDA	Current
70010-160	ACETAMINOPHEN	ACETAMINOPHEN	Granules Pharmaceuticals Inc.	ANDA	Current
70677-0168	pain reliever	Acetaminophen	STRATEGIC SOURCING SERVICES LLC	ANDA	Current
71309-011	ACETAMINOPHEN	ACETAMINOPHEN	Safrel Pharmaceuticals, LLC.	ANDA	Current
71335-1340	ACETAMINOPHEN	ACETAMINOPHEN	Bryant Ranch Prepack	ANDA	Current
71335-1340	ACETAMINOPHEN	ACETAMINOPHEN	Bryant Ranch Prepack	ANDA	Current
71335-1340	ACETAMINOPHEN	ACETAMINOPHEN	Bryant Ranch Prepack	ANDA	Current
72036-200	8HR Arthritis Pain	Acetaminophen	HARRIS TEETER	ANDA	Current
72476-185	Acetaminophen	Acetaminophen	RETAIL BUSINESS SERVICES,LLC.	ANDA	Current
72476-185	Acetaminophen	Acetaminophen	RETAIL BUSINESS SERVICES,LLC.	ANDA	Current
72476-186	Acetaminophen	Acetaminophen	RETAIL BUSINESS SERVICES,LLC.	ANDA	Current
72476-186	Acetaminophen	Acetaminophen	RETAIL BUSINESS SERVICES,LLC.	ANDA	Current
79903-137	Acetaminophen	Acetaminophen	WAL-MART STORES INC	ANDA	Current