Application 018832

Type: NDA
Sponsor: WATSON LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	ALLOPURINOL	ALLOPURINOL	TABLET;ORAL	100MG	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
N018832-002	ALLOPURINOL	ALLOPURINOL	100MG	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
N018832-002	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	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018832-002	ALLOPURINOL	100MG	TABLET / ORAL	AB	1984-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018832-002	ALLOPURINOL	100MG	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	N018832-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018832-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018832-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018832-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018832-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018832-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018832-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018832-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018832-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018832-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018832-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018832-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018832-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018832-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018832-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018832-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018832-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018832-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018832-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018832-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018832-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018832-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018832-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018832-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018832-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018832-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018832-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018832-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018832-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018832-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018832-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018832-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018832-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018832-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018832-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018832-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018832-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018832-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018832-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018832-002	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Actavis Pharma, Inc.	a80fe56f-8d03-423f-8e2a-7ec8c9e5045b	2024-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018832 application number: NDA018832 ndc (product): 0591-5543
Allopurinol	ALLOPURINOL	Proficient Rx LP	0ca4baed-c5d8-4de4-ac17-6e5d1df15c03	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018832 application number: NDA018832 ndc (product): 63187-463

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-5543	Allopurinol	Allopurinol	Actavis Pharma, Inc.	NDA	Current
0591-5543	Allopurinol	Allopurinol	Actavis Pharma, Inc.	NDA	Current
0615-8321	Allopurinol	Allopurinol	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
0615-8321	Allopurinol	Allopurinol	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
0615-8321	Allopurinol	Allopurinol	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
21695-246	Allopurinol	Allopurinol	Rebel Distributors Corp.	ANDA	Current
21695-836	Allopurinol	Allopurinol	Rebel Distributors Corp.	ANDA	Current
33261-810	Allopurinol	Allopurinol	Aidarex Pharmaceuticals LLC	NDA	Current
43063-793	Allopurinol	Allopurinol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-793	Allopurinol	Allopurinol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-793	Allopurinol	Allopurinol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-793	Allopurinol	Allopurinol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-793	Allopurinol	Allopurinol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
49999-374	Allopurinol	Allopurinol	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
49999-374	Allopurinol	Allopurinol	Lake Erie Medical DBA Qua	ANDA	Current
50090-2544	Allopurinol	Allopurinol	A-S Medication Solutions	NDA	Current
50090-2544	Allopurinol	Allopurinol	A-S Medication Solutions	NDA	Current
53217-187	Allopurinol	Allopurinol	Aidarex Pharmaceuticals LLC	NDA	Current
53808-0604	Allopurinol	ALLOPURINOL	State of Florida DOH Central Pharmacy	NDA	Current
53808-0755	Allopurinol	ALLOPURINOL	State of Florida DOH Central Pharmacy	NDA	Current
55154-2056	Allopurinol	Allopurinol	Cardinal Health	NDA	Current
55154-4750	Allopurinol	Allopurinol	Cardinal Health	NDA	Current
62584-988	Allopurinol	Allopurinol	American Health Packaging	NDA	Current
62584-988	Allopurinol	Allopurinol	American Health Packaging	NDA	Current
62584-988	Allopurinol	Allopurinol	American Health Packaging	NDA	Current
62584-988	Allopurinol	Allopurinol	American Health Packaging	NDA	Current
63187-463	Allopurinol	Allopurinol	Proficient Rx LP	NDA	Current
63187-463	Allopurinol	Allopurinol	Proficient Rx LP	NDA	Current
63187-463	Allopurinol	Allopurinol	Proficient Rx LP	NDA	Current
63187-463	Allopurinol	Allopurinol	Proficient Rx LP	NDA	Current
63629-1675	Allopurinol	Allopurinol	Bryant Ranch Prepack	NDA	Current
63629-1675	Allopurinol	Allopurinol	Bryant Ranch Prepack	NDA	Current
63629-6508	Allopurinol	Allopurinol	Bryant Ranch Prepack	NDA	Current
63629-6508	Allopurinol	Allopurinol	Bryant Ranch Prepack	NDA	Current
63629-6508	Allopurinol	Allopurinol	Bryant Ranch Prepack	NDA	Current
63629-6508	Allopurinol	Allopurinol	Bryant Ranch Prepack	NDA	Current
67296-1265	Allopurinol	Allopurinol	RedPharm Drug, Inc.	NDA	Current
67296-1265	Allopurinol	Allopurinol	RedPharm Drug, Inc.	NDA	Current
67296-1265	Allopurinol	Allopurinol	RedPharm Drug, Inc.	NDA	Current
68071-4131	Allopurinol	Allopurinol	NuCare Pharmaceuticals,Inc.	NDA	Current
70518-0555	Allopurinol	Allopurinol	REMEDYREPACK INC.	NDA	Current
70518-0555	Allopurinol	Allopurinol	REMEDYREPACK INC.	NDA	Current
70518-1678	Allopurinol	Allopurinol	REMEDYREPACK INC.	NDA	Current
70518-1678	Allopurinol	Allopurinol	REMEDYREPACK INC.	NDA	Current
70518-1678	Allopurinol	Allopurinol	REMEDYREPACK INC.	NDA	Current
70518-1678	Allopurinol	Allopurinol	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78067	SUPPL	2024-04-04
78066	SUPPL	2024-04-04
78065	SUPPL	2024-04-04
78053	SUPPL	2024-04-03
78052	SUPPL	2024-04-03
78051	SUPPL	2024-04-03