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 6 of 7 · 133 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	f91c2183-e41d-45bc-87aa-edfca5eebac5	2024-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	005048dd-844f-468c-bf56-1a09727e3477	2024-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	NuCare Pharmaceuticals,Inc.	1b1c5cde-b2ed-ebc8-e063-6394a90a66c6	2024-06-17	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	7003e410-b4ff-da07-5571-07e7e13f67e0	2024-05-22	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Advanced Rx Pharmacy of Tennessee, LLC	15d758f9-2ec5-ecf5-e063-6394a90a7a2c	2024-04-11	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	A-S Medication Solutions	3db4e043-71ff-496a-8087-3fde0e352abf	2024-04-11	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	A-S Medication Solutions	71accbc4-8bd7-4d22-ae53-c7b044a15ffa	2024-04-11	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	A-S Medication Solutions	2caa5246-9422-4826-b926-a2566506d3eb	2024-04-11	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	A-S Medication Solutions	7bf1be4e-72ba-407c-90b3-b70b09a25d6e	2024-04-10	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	A-S Medication Solutions	11f1fc6e-b274-4132-9edd-522a819a479b	2024-04-10	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	A-S Medication Solutions	420d338d-4d0d-4e38-bfe2-a83256821b45	2024-04-10	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	90912dd4-5abf-4fd3-8fc1-3afd057b743f	2024-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	e84cd8df-79d8-449f-ace2-5a4de1cdaf51	2024-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Actavis Pharma, Inc.	a80fe56f-8d03-423f-8e2a-7ec8c9e5045b	2024-04-01	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Par Health USA, LLC	fbac3b4f-dc23-4359-ac3f-2b3fdde41af2	2024-01-30	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Proficient Rx LP	0ca4baed-c5d8-4de4-ac17-6e5d1df15c03	2023-02-01	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Fresenius Kabi USA, LLC	2caf5eed-2408-4ce0-bd0d-04f4c90e434d	2023-01-24	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	9b0e3f11-c02a-443d-806f-134c907ea371	2022-12-21	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	a5c35283-09d2-4bb4-bdd1-055035fa272b	2022-12-13	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	0155151c-6e84-4f9b-9233-60ffa7483293	2022-11-28	Warnings, Adverse reactions	Name fallback generic name: ALLOPURINOL

Reported adverse events (FAERS/openFDA)#

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