Application 203154

Type: ANDA
Sponsor: ACCORD HLTHCARE

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

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
A203154-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06
A203154-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203154-001	AB
A203154-002	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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2013-05-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A203154-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203154-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203154-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203154-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203154-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203154-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203154-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203154-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203154-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203154-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203154-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203154-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203154-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203154-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203154-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203154-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203154-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203154-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203154-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203154-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203154-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203154-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203154-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203154-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203154-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203154-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203154-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203154-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203154-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203154-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203154-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203154-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203154-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203154-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203154-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203154-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203154-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203154-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203154-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203154-002	AB	1	`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 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	3bcd1381-34d9-4fa5-bfc5-2566cb7a7638	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154 ndc (product): 71335-0467
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	76ed9122-b845-423b-a6d5-a47b31743317	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154 ndc (product): 71335-0112
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	eb1b1aa6-cbd3-4b06-b9f9-9a0779a2da08	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	Northwind Health Company, LLC	f3198e1b-6344-ad96-e053-2995a90a4aaf	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	Accord Healthcare Inc.	682dd8b8-fc6e-47c5-95b7-82d7ad96b750	2025-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	Advanced Rx Pharmacy of Tennessee, LLC	ec09fbcf-6e20-8438-e053-2a95a90a6376	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154 ndc (product): 80425-0206
Allopurinol	ALLOPURINOL	NuCare Pharmaceuticals, Inc.	44bcc8df-a803-010f-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	A-S Medication Solutions	71accbc4-8bd7-4d22-ae53-c7b044a15ffa	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	0155151c-6e84-4f9b-9233-60ffa7483293	2022-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154 ndc (product): 71610-678
Allopurinol	ALLOPURINOL	Proficient Rx LP	d94f6643-621f-45ed-b2dc-26f84c5626ae	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154

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 2 of 2 · 87 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71335-0112	Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	ANDA	Current
71335-0467	Allopurinol	allopurinol	Bryant Ranch Prepack	ANDA	Current
71335-0467	Allopurinol	allopurinol	Bryant Ranch Prepack	ANDA	Current
71335-0467	Allopurinol	allopurinol	Bryant Ranch Prepack	ANDA	Current
71610-231	Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-678	Allopurinol	allopurinol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
80425-0206	Allopurinol	Allopurinol	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current