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 1.

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 · 82 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
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078253-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2007-09-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078253-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2007-09-11	`782e0a99824c…`

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 1 of 7 · 132 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Cardinal Health 107, LLC	ced59048-c147-4702-af32-2f9b517ed87a	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Cardinal Health 107, LLC	b6c5b5c0-b1cb-44c0-a849-5d317e6fa300	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	REMEDYREPACK INC.	55280a8a-cf23-405b-b698-95a4d8e3c699	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	6341a72d-9c83-448c-871b-e800ad8f1547	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
ALLOPURINOL	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	5644814c-3f61-5338-e063-6294a90ad6c9	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: ALLOPURINOL generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Major Pharmaceuticals	8c0f5af5-a453-4641-933f-ccb2625fca39	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	156d743c-6324-44db-9230-21f762d64cfd	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	b943dbb1-7f54-434c-9439-8ce768d94ff4	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	St. Mary's Medical Park Pharmacy	0f8b97d0-4d0b-9f4a-e063-6294a90a033f	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	St. Mary's Medical Park Pharmacy	00b27899-e68f-e9d9-e063-6394a90a88cb	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Major Pharmaceuticals	b630c1cb-d4b7-4f80-b252-5947c1887def	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	PD-Rx Pharmaceuticals, Inc.	b2ab2389-ccaf-487b-9985-50e3539e7617	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	PD-Rx Pharmaceuticals, Inc.	211e47c6-85b9-43e8-9e07-6cc4b8f708a0	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	PD-Rx Pharmaceuticals, Inc.	f1c11f74-1de2-484c-b40b-d0013e8fd01a	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	PD-Rx Pharmaceuticals, Inc.	f130c9c0-45d8-42bc-a040-04bb077671f8	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Rising Pharma Holdings, Inc.	30ad5ba2-1cef-4933-b104-0597f6a2aaa2	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	3bcd1381-34d9-4fa5-bfc5-2566cb7a7638	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	76ed9122-b845-423b-a6d5-a47b31743317	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	1f626471-153c-4740-8019-9089ea741684	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	fc37bc7e-b6bc-4aa9-a6f3-6e11285c4f05	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL

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