Application 075798

Type: ANDA
Sponsor: VINTAGE PHARMS

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 42.

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
A075798-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB		2003-06-27
A075798-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB		2003-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075798-001	AB
A075798-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075798-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2003-06-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075798-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2003-06-27	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075798-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075798-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075798-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075798-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075798-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075798-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075798-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075798-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075798-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075798-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075798-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075798-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075798-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075798-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075798-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075798-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075798-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075798-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075798-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075798-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075798-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075798-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075798-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075798-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075798-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075798-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075798-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075798-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075798-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075798-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075798-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075798-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075798-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075798-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075798-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075798-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075798-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075798-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075798-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075798-002	AB	1	`bb7c543d1eb4…`

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	Cardinal Health 107, LLC	b6c5b5c0-b1cb-44c0-a849-5d317e6fa300	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798 ndc (product): 55154-7981
Allopurinol	ALLOPURINOL	Major Pharmaceuticals	8c0f5af5-a453-4641-933f-ccb2625fca39	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798 ndc (product): 0904-6572
Allopurinol	ALLOPURINOL	NCS HealthCare of KY, LLC dba Vangard Labs	1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c3	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798 ndc (product): 0615-8385
Allopurinol	ALLOPURINOL	REMEDYREPACK INC.	4dbced9a-ef6f-455e-8d5d-b635409521db	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	73a374a6-ea1a-40a1-b6eb-d42654df0895	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798 ndc (product): 63629-2112
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	f91c2183-e41d-45bc-87aa-edfca5eebac5	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798 ndc (product): 63629-2111
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	005048dd-844f-468c-bf56-1a09727e3477	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798 ndc (product): 63629-2113
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	90912dd4-5abf-4fd3-8fc1-3afd057b743f	2024-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	e84cd8df-79d8-449f-ace2-5a4de1cdaf51	2024-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798
Allopurinol	ALLOPURINOL	Par Health USA, LLC	fbac3b4f-dc23-4359-ac3f-2b3fdde41af2	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075798 application number: ANDA075798 ndc (product): 0603-2115 ndc (product): 0603-2116

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 58 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-2115	Allopurinol	allopurinol	Par Pharmaceutical	ANDA	Current
0603-2115	Allopurinol	allopurinol	Par Pharmaceutical	ANDA	Current
0603-2115	Allopurinol	allopurinol	Par Pharmaceutical	ANDA	Current
0603-2115	Allopurinol	allopurinol	Par Pharmaceutical	ANDA	Current
0603-2115	Allopurinol	allopurinol	Par Pharmaceutical, Inc.	ANDA	Current
0603-2116	Allopurinol	allopurinol	Par Pharmaceutical	ANDA	Current
0603-2116	Allopurinol	allopurinol	Par Pharmaceutical	ANDA	Current
0603-2116	Allopurinol	allopurinol	Par Pharmaceutical	ANDA	Current
0603-2116	Allopurinol	allopurinol	Par Pharmaceutical	ANDA	Current
0603-2116	Allopurinol	allopurinol	Par Pharmaceutical, Inc.	ANDA	Current
0615-8385	Allopurinol	allopurinol	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0904-6571	Allopurinol	allopurinol	Major Pharmaceuticals	ANDA	Current
0904-6571	Allopurinol	allopurinol	Major Pharmaceuticals	ANDA	Current
0904-6571	Allopurinol	allopurinol	Major Pharamceuticals	ANDA	Current
0904-6572	Allopurinol	allopurinol	Major Pharmaceuticals	ANDA	Current
0904-6572	Allopurinol	allopurinol	Major Pharmaceuticals	ANDA	Current
0904-6572	Allopurinol	allopurinol	Major Pharmaceuticals	ANDA	Current
0904-6572	Allopurinol	allopurinol	Major Pharamceuticals	ANDA	Current
0904-6572	Allopurinol	allopurinol	Major Pharmaceuticals	ANDA	Current
43063-079	Allopurinol	allopurinol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-079	Allopurinol	allopurinol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-079	Allopurinol	allopurinol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-079	Allopurinol	allopurinol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-079	Allopurinol	allopurinol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50268-063	Allopurinol	allopurinol	AvPAK	ANDA	Current
50268-063	Allopurinol	allopurinol	AvPAK	ANDA	Current
50268-063	Allopurinol	allopurinol	AvPAK	ANDA	Current
50268-064	Allopurinol	allopurinol	AvPAK	ANDA	Current
50268-064	Allopurinol	allopurinol	AvPAK	ANDA	Current
50268-064	Allopurinol	allopurinol	AvPAK	ANDA	Current
55154-7892	Allopurinol	allopurinol	Cardinal Health	ANDA	Current
55154-7892	Allopurinol	allopurinol	Cardinal Health	ANDA	Current
55154-7981	Allopurinol	allopurinol	Cardinal Health 107, LLC	ANDA	Current
55154-7981	Allopurinol	allopurinol	Cardinal Health	ANDA	Current
55154-7981	Allopurinol	allopurinol	Cardinal Health	ANDA	Current
55289-010	Allopurinol	allopurinol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-010	Allopurinol	allopurinol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-010	Allopurinol	allopurinol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-010	Allopurinol	allopurinol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-010	Allopurinol	allopurinol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-010	Allopurinol	allopurinol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55700-035	Allopurinol	allopurinol	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60760-114	Allopurinol	ALLOPURINOL	St Marys Medical Park Pharmacy	ANDA	Current
63629-2111	Allopurinol	allopurinol	Bryant Ranch Prepack	ANDA	Current
63629-2111	Allopurinol	allopurinol	Bryant Ranch Prepack	ANDA	Current
63629-2111	Allopurinol	allopurinol	Bryant Ranch Prepack	ANDA	Current
63629-2112	Allopurinol	allopurinol	Bryant Ranch Prepack	ANDA	Current
63629-2112	Allopurinol	allopurinol	Bryant Ranch Prepack	ANDA	Current
63629-2113	Allopurinol	allopurinol	Bryant Ranch Prepack	ANDA	Current
63629-2113	Allopurinol	allopurinol	Bryant Ranch Prepack	ANDA	Current
67046-008	Allopurinol	allopurinol	Contract Pharmacy Services-PA	ANDA	Current
67296-1314	Allopurinol	Allopurinol	RedPharm Drug, Inc.	ANDA	Current
67296-1314	Allopurinol	Allopurinol	RedPharm Drug, Inc.	ANDA	Current
67296-1314	Allopurinol	Allopurinol	RedPharm Drug, Inc.	ANDA	Current
67544-371	Allopurinol	allopurinol	Aphena Pharma Solutions - Tennessee, Inc.	ANDA	Current
67544-988	Allopurinol	allopurinol	Aphena Pharma Solutions - Tennessee, Inc.	ANDA	Current
70518-0190	Allopurinol	allopurinol	REMEDYREPACK INC.	ANDA	Current
70518-0476	Allopurinol	allopurinol	REMEDYREPACK INC.	ANDA	Current