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 2 of 7 · 133 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	St. Mary's Medical Park Pharmacy	0f8b97d0-4d0b-9f4a-e063-6294a90a033f	2026-06-04	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	St. Mary's Medical Park Pharmacy	00b27899-e68f-e9d9-e063-6394a90a88cb	2026-06-03	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Major Pharmaceuticals	b630c1cb-d4b7-4f80-b252-5947c1887def	2026-06-01	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Rising Pharma Holdings, Inc.	30ad5ba2-1cef-4933-b104-0597f6a2aaa2	2026-05-21	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	3bcd1381-34d9-4fa5-bfc5-2566cb7a7638	2026-05-21	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	76ed9122-b845-423b-a6d5-a47b31743317	2026-05-19	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	1f626471-153c-4740-8019-9089ea741684	2026-05-15	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	fc37bc7e-b6bc-4aa9-a6f3-6e11285c4f05	2026-05-13	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
ALLOPURINOL	ALLOPURINOL	Northwind Health Company, LLC	4deeebe3-fccc-2082-e063-6294a90a0c78	2026-05-11	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Cardinal Health 107, LLC	1ce96b87-323d-40b6-a40b-32821e00d94c	2026-04-20	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Aurobindo Pharma Limited	311ca755-c022-4251-97eb-dd9be86a993f	2026-04-17	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	30529a62-f95a-40e0-b4c5-2cfc09232068	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	8ae2d634-df53-40a8-a6bd-6fee7dacd754	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	ST. MARY'S MEDICAL PARK PHARMACY	4f5c4fbc-3d31-5068-e063-6294a90ab315	2026-04-13	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	5dca2d4f-0e93-4d1a-8d9f-b9b72867c242	2026-04-13	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Cardinal Health 107, LLC	2462b4b5-8313-4e4d-93ac-839de4a29520	2026-04-08	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Safecor Health, LLC	dbfb3bde-2274-43cc-b726-d4578ebdb5d4	2026-04-01	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Direct_Rx	f6c83ee9-c07b-9fc8-e053-6394a90a2160	2026-03-05	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
ALLOPURINOL	ALLOPURINOL	Direct_Rx	f3bd5852-8e43-6b5d-e053-2995a90a194f	2026-03-05	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Chartwell RX, LLC	cdc3f33b-ff2b-4a84-a820-51a497fdf3d9	2026-02-20	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL

Reported adverse events (FAERS/openFDA)#

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