Application 018297

Type: NDA
Sponsor: ABBOTT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOPURIN	ALLOPURINOL	TABLET;ORAL	100MG	No	No
002	LOPURIN	ALLOPURINOL	TABLET;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018297-001	LOPURIN	ALLOPURINOL	100MG	TABLET / ORAL		Approved before 1982
N018297-002	LOPURIN	ALLOPURINOL	300MG	TABLET / ORAL		Approved before 1982

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018297-001	LOPURIN	100MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018297-002	LOPURIN	300MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`

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 4 of 7 · 133 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	A-S Medication Solutions	5efa81be-e2c9-4fb7-bd0d-aeca3920a393	2025-12-30	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	A-S Medication Solutions	f26674cd-d2b7-433c-a593-6a52012b81e3	2025-12-30	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ad6950d4-2cdd-44ac-9b8a-120716460e70	2025-12-29	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Northwind Health Company, LLC	f67d4aa7-6e5f-bba1-e053-2a95a90a1194	2025-12-26	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
ALLOPURINOL	ALLOPURINOL	A-S Medication Solutions	c476ae27-fa13-480c-8d02-58c2c2904b84	2025-11-26	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
ALLOPURINOL	ALLOPURINOL	A-S Medication Solutions	8047206e-305b-44d2-aa61-dff0366e7675	2025-11-26	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Mylan Pharmaceuticals Inc.	bdbf5ad4-86f2-4e9c-a51a-fb0c7220c480	2025-11-20	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	ST. MARY'S MEDICAL PARK PHARMACY	42de3b18-a289-e49e-e063-6394a90a89d4	2025-11-05	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Direct_Rx	426262e6-8219-c825-e063-6294a90a21a9	2025-10-30	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
ALLOPURINOL	ALLOPURINOL	A-S Medication Solutions	78978de2-1842-4570-9d11-67f13cc37ad5	2025-10-14	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
ALLOPURINOL	ALLOPURINOL	A-S Medication Solutions	5955ca3f-9383-4025-ac58-90394716493a	2025-10-14	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Accord Healthcare Inc.	682dd8b8-fc6e-47c5-95b7-82d7ad96b750	2025-10-06	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
ALLOPURINOL	ALLOPURINOL	Bryant Ranch Prepack	e453a5e0-44c3-4eb5-a8d0-7c02157d2f8c	2025-10-02	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
ALLOPURINOL	ALLOPURINOL	Preferred Pharmaceuticals Inc.	d83fec65-396a-40bd-8ee8-828d8930ea41	2025-09-22	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	3f0134bf-b62f-1077-e063-6394a90a60b0	2025-09-17	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Indoco Remedies Limited	48a9a6c3-4604-421e-a323-1133888aaf76	2025-08-21	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Mylan Institutional Inc.	994b3117-b83e-44d9-910c-1c3a26ef838e	2025-07-18	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	NuCare Pharmaceuticals,Inc.	3845c310-099b-8e11-e063-6394a90abd2f	2025-06-23	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Zydus Lifesciences Limited	9232f484-a5f6-4c63-b7f4-b510d2827159	2025-06-18	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
ALLOPURINOL	ALLOPURINOL	Advanced Rx of Tennessee, LLC	36c1c908-1eed-ed2a-e063-6294a90a16f9	2025-05-29	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.