Application 204467

Type: ANDA
Sponsor: INDOCO REMEDIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALLOPURINOL	ALLOPURINOL	TABLET;ORAL	100MG	No	No
002	ALLOPURINOL	ALLOPURINOL	TABLET;ORAL	300MG	No	No
003	ALLOPURINOL	ALLOPURINOL	TABLET;ORAL	200MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204467-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28
A204467-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28
A204467-003	ALLOPURINOL	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204467-001	AB
A204467-002	AB
A204467-003	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 3 · 92 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
2026-09-14 22:38:34	2026-08	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204467-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-05-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204467-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204467-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204467-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204467-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`5d02ea3f76ae…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204467-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204467-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204467-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204467-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204467-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204467-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204467-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204467-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204467-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204467-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204467-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204467-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204467-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204467-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204467-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204467-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204467-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204467-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204467-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204467-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204467-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204467-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204467-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204467-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204467-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204467-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204467-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204467-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204467-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204467-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204467-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204467-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204467-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204467-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204467-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204467-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204467-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204467-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204467-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204467-001	AB	1	`5d02ea3f76ae…`

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	NorthStar RxLLC	95a1ca8c-9855-4b11-92cd-6fdc144f0d3b	2024-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467 ndc (product): 16714-577 ndc (product): 16714-576
Allopurinol	ALLOPURINOL	NuCare Pharmaceuticals,Inc.	1b1c5cde-b2ed-ebc8-e063-6394a90a66c6	2024-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	A-S Medication Solutions	7bf1be4e-72ba-407c-90b3-b70b09a25d6e	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	A-S Medication Solutions	11f1fc6e-b274-4132-9edd-522a819a479b	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	A-S Medication Solutions	420d338d-4d0d-4e38-bfe2-a83256821b45	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	a5c35283-09d2-4bb4-bdd1-055035fa272b	2022-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467 ndc (product): 71610-681
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	f99f4637-4d67-4b3c-8741-b775a9d0bde1	2022-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467 ndc (product): 71610-676

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-576	Allopurinol	Allopurinol	NorthStar RxLLC	ANDA	Current
16714-577	Allopurinol	Allopurinol	NorthStar RxLLC	ANDA	Current
23155-693	Allopurinol	Allopurinol	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-693	Allopurinol	Allopurinol	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-693	Allopurinol	Allopurinol	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-694	Allopurinol	Allopurinol	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-694	Allopurinol	Allopurinol	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-694	Allopurinol	Allopurinol	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
50742-135	Allopurinol	Allopurinol	Ingenus Pharmaceuticals LLC	ANDA	Current
50742-136	Allopurinol	Allopurinol	Ingenus Pharmaceuticals LLC	ANDA	Current
51655-945	Allopurinol	Allopurinol	Northwind Pharmaceuticals	ANDA	Current
69967-008	Allopurinol	Allopurinol	Arise Pharamaceuticals LLC	ANDA	Current
69967-009	Allopurinol	Allopurinol	Arise Pharamaceuticals LLC	ANDA	Current
70934-979	Allopurinol	Allopurinol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-979	Allopurinol	Allopurinol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71610-676	Allopurinol	Allopurinol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-681	Allopurinol	Allopurinol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current