Application 018877

Type: NDA
Sponsor: WATSON LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALLOPURINOL	ALLOPURINOL	TABLET;ORAL	300MG	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
N018877-001	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB		1984-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N018877-001	AB

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	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018877-001	ALLOPURINOL	300MG	TABLET / ORAL	AB	1984-09-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N018877-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018877-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018877-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018877-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018877-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018877-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018877-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018877-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018877-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018877-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018877-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018877-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018877-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018877-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018877-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018877-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018877-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018877-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018877-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018877-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018877-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018877-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018877-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018877-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018877-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018877-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018877-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018877-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018877-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018877-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018877-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018877-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018877-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018877-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018877-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018877-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018877-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018877-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018877-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018877-001	AB	1	`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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	7003e410-b4ff-da07-5571-07e7e13f67e0	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018877 application number: NDA018877 ndc (product): 63629-1781
Allopurinol	ALLOPURINOL	Actavis Pharma, Inc.	a80fe56f-8d03-423f-8e2a-7ec8c9e5045b	2024-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018877 application number: NDA018877 ndc (product): 0591-5544
Allopurinol	ALLOPURINOL	Proficient Rx LP	0ca4baed-c5d8-4de4-ac17-6e5d1df15c03	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018877 application number: NDA018877 ndc (product): 63187-240
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	9b0e3f11-c02a-443d-806f-134c907ea371	2022-12-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018877 application number: NDA018877 ndc (product): 67544-313

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-5544	Allopurinol	Allopurinol	Actavis Pharma, Inc.	NDA	Current
0591-5544	Allopurinol	Allopurinol	Actavis Pharma, Inc.	NDA	Current
33261-597	Allopurinol	Allopurinol	Aidarex Pharmaceuticals LLC	NDA	Current
43063-774	Allopurinol	Allopurinol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-774	Allopurinol	Allopurinol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-774	Allopurinol	Allopurinol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-774	Allopurinol	Allopurinol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-774	Allopurinol	Allopurinol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
49999-374	Allopurinol	Allopurinol	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
49999-374	Allopurinol	Allopurinol	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
52959-311	Allopurinol	Allopurinol	H. J. Harkins Company Inc	NDA	Current
53002-4821	Allopurinol	Allopurinol	RPK Pharmaceuticals, Inc.	NDA	Current
55700-540	Allopurinol	Allopurinol	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
55700-540	Allopurinol	Allopurinol	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
55700-540	Allopurinol	Allopurinol	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
62584-713	Allopurinol	Allopurinol	American Health Packaging	NDA	Current
62584-713	Allopurinol	Allopurinol	American Health Packaging	NDA	Current
62584-713	Allopurinol	Allopurinol	American Health Packaging	NDA	Current
62584-713	Allopurinol	Allopurinol	American Health Packaging	NDA	Current
63187-240	Allopurinol	Allopurinol	Proficient Rx LP	NDA	Current
63187-240	Allopurinol	Allopurinol	Proficient Rx LP	NDA	Current
63187-240	Allopurinol	Allopurinol	Proficient Rx LP	NDA	Current
63187-240	Allopurinol	Allopurinol	Proficient Rx LP	NDA	Current
63629-1781	Allopurinol	Allopurinol	Bryant Ranch Prepack	NDA	Current
63629-1781	Allopurinol	Allopurinol	Bryant Ranch Prepack	NDA	Current
63629-6405	Allopurinol	Allopurinol	Bryant Ranch Prepack	NDA	Current
63629-6405	Allopurinol	Allopurinol	Bryant Ranch Prepack	NDA	Current
67544-313	Allopurinol	Allopurinol	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
68788-9831	Allopurinol	Allopurinol	Preferred Pharmaceuticals, Inc.	NDA	Current
70518-0429	Allopurinol	Allopurinol	REMEDYREPACK INC.	NDA	Current
70518-1573	Allopurinol	Allopurinol	REMEDYREPACK INC.	NDA	Current
70518-1573	Allopurinol	Allopurinol	REMEDYREPACK INC.	NDA	Current
70518-1573	Allopurinol	Allopurinol	REMEDYREPACK INC.	NDA	Current
70518-1573	Allopurinol	Allopurinol	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78070	SUPPL	2024-04-04
78069	SUPPL	2024-04-04
78068	SUPPL	2024-04-04
78056	SUPPL	2024-04-03
78055	SUPPL	2024-04-03
78054	SUPPL	2024-04-03