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 5 of 7 · 133 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	American Health Packaging	f6f7642b-5046-47d6-b259-0c9f8aed3b34	2025-05-14	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
ALLOPURINOL	ALLOPURINOL	Preferred Pharmaceuticals Inc.	09d34fab-250c-496a-93f5-c8d9f52a2276	2025-04-23	Warnings, Adverse reactions	Name fallback brand name: ALLOPURINOL generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Zydus Pharmaceuticals (USA) Inc.	8b926e62-3a9c-424a-833a-8169e55a1f15	2025-04-07	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	NuCare Pharmaceuticals, Inc.	2f27f578-f965-04c9-e063-6394a90a1ae2	2025-02-27	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Coupler LLC	2d6ce57f-a9df-319e-e063-6394a90ac93f	2025-02-05	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	NuCare Pharmaceuticals,Inc.	faf55184-6962-d49f-e053-6394a90a152e	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	5a1bfae2-116f-4ef9-bb7b-3b69ac74df03	2025-01-30	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Redpharm Drug	0a22fa72-c363-4e96-e063-6394a90a48aa	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Harman Finochem Limited	0780dc78-d287-d5db-e063-6294a90aa1dd	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	7f9ad8db-ae68-4a0c-b858-1e727bc98130	2025-01-03	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Advanced Rx Pharmacy of Tennessee, LLC	ec09fbcf-6e20-8438-e053-2a95a90a6376	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	A-S Medication Solutions	74dba96f-d388-40fe-8bca-53086d28c954	2024-12-24	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	92253e70-0b0c-4a0c-9bd6-ccea91000819	2024-12-10	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	A-S Medication Solutions	d9a20bf5-15b9-4643-b829-40eacd4e849d	2024-10-21	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	A-S Medication Solutions	869e09f7-fb72-4e15-8d4b-849e86ebc6fd	2024-10-21	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
ALLOPURINOL	ALLOPURINOL	Camber Pharmaceuticals, Inc.	60750373-7146-455a-8d12-d0e32d2d4bc8	2024-10-17	Warnings, Adverse reactions	Name fallback brand name: ALLOPURINOL generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	NorthStar RxLLC	95a1ca8c-9855-4b11-92cd-6fdc144f0d3b	2024-09-13	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	NuCare Pharmaceuticals, Inc.	20eef55e-0d70-874b-e063-6394a90aa06a	2024-08-30	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	NuCare Pharmaceuticals, Inc.	44bcc8df-a803-010f-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Allopurinol generic name: ALLOPURINOL
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	73a374a6-ea1a-40a1-b6eb-d42654df0895	2024-07-08	Boxed warning, 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