Application 078253

Type: ANDA
Sponsor: NORTHSTAR 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
A078253-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL			2007-09-11
A078253-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL			2007-09-11

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL		2007-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL		2007-09-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL		2007-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL		2007-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL		2007-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL		2007-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL		2007-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL		2007-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A078253-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078253-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078253-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078253-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078253-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078253-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078253-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078253-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078253-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078253-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078253-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078253-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078253-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078253-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078253-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078253-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078253-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078253-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078253-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078253-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078253-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078253-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078253-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078253-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078253-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078253-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078253-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078253-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078253-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078253-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078253-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078253-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078253-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078253-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078253-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078253-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078253-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078253-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078253-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078253-002	AB	1	`5aa47cf7b7d7…`

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 3 of 7 · 133 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	7c7eafa6-5411-470c-8a45-cfbc85d3e335	2026-02-18	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	92d9a9d1-76c0-4435-984d-48f44b452855	2026-02-18	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	eb1b1aa6-cbd3-4b06-b9f9-9a0779a2da08	2026-02-18	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	b3b9dcf4-cada-4f79-befc-319c7dff15eb	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	e11e94b9-d897-48ce-9a80-aa6b8b5fde02	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	6d2f2f76-0f2b-45c4-affe-77bd927df589	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Coupler LLC	4a00a35a-cc85-0088-e063-6394a90a0744	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
ALLOPURINOL	ALLOPURINOL	Bryant Ranch Prepack	d9961781-cfe8-459b-920d-eb000d45d41f	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: ALLOPURINOL generic name: ALLOPURINOL
ALLOPURINOL	ALLOPURINOL	REMEDYREPACK INC.	20015399-43f8-4917-8ffe-dd8055c75712	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: ALLOPURINOL generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Florida Pharmaceutical Products, LLC	815af471-5985-4819-936d-1f5f3d871ef8	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Unichem Pharmaceuticals (USA), Inc.	e3face45-f920-46a0-b707-6a66aa9735bd	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	REMEDYREPACK INC.	52ce5aab-76cf-465d-8f14-c745d382cd15	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	NCS HealthCare of KY, LLC dba Vangard Labs	1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c3	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Coupler LLC	47b8c920-4648-604e-e063-6294a90a1f54	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
ALLOPURINOL	ALLOPURINOL	XLCare Pharmaceuticals Inc.	fc7973c8-d846-4eca-ab0d-d30228035ba2	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: ALLOPURINOL generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Northwind Health Company, LLC	f3198e1b-6344-ad96-e053-2995a90a4aaf	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Northwind Health Company, LLC	df745f5f-7f05-205d-e053-2995a90a05a4	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Northwind Health Company, LLC	df754efc-4b73-a0ab-e053-2a95a90a6133	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Northwind Health Company, LLC	fe06da1b-c493-e238-e053-6294a90a9195	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Northwind Health Company, LLC	da814597-50e6-48fa-e053-2995a90ab21b	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL

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 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-041	Allopurinol	Allopurinol	Northstar RxLLC	ANDA	Current
16714-041	Allopurinol	Allopurinol	Northstar RxLLC	ANDA	Current
16714-042	Allopurinol	Allopurinol	Northstar RxLLC	ANDA	Current
16714-042	Allopurinol	Allopurinol	Northstar RxLLC	ANDA	Current
43353-501	Allopurinol	Allopurinol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-0042	Allopurinol	Allopurinol	A-S Medication Solutions	ANDA	Current
50090-0042	Allopurinol	Allopurinol	A-S Medication Solutions	ANDA	Current
50090-0044	Allopurinol	Allopurinol	A-S Medication Solutions	ANDA	Current
63739-410	Allopurinol	Allopurinol	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-410	Allopurinol	Allopurinol	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-410	Allopurinol	Allopurinol	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-410	Allopurinol	Allopurinol	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-410	Allopurinol	Allopurinol	McKesson Corporation	ANDA	Current
63739-796	Allopurinol	Allopurinol	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-796	Allopurinol	Allopurinol	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-796	Allopurinol	Allopurinol	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-796	Allopurinol	Allopurinol	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-796	Allopurinol	Allopurinol	McKesson Corporation	ANDA	Current
68071-2616	Allopurinol	Allopurinol	NuCare Pharmaceuticals,Inc.	ANDA	Current