Application 214443

Type: ANDA
Sponsor: HARMAN FINOCHEM

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
003	ALLOPURINOL	ALLOPURINOL	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214443-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07
A214443-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07
A214443-003	ALLOPURINOL	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A214443-001	AB
A214443-002	AB
A214443-003	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 2 · 75 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	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214443-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2024-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214443-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2022-03-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214443-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2022-03-07	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214443-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214443-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214443-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214443-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214443-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214443-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214443-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214443-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214443-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214443-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214443-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214443-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214443-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214443-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214443-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214443-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214443-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214443-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214443-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214443-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214443-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214443-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214443-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214443-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214443-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214443-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214443-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214443-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214443-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214443-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214443-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214443-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214443-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214443-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214443-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214443-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214443-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214443-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214443-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214443-002	AB	1	`8072bd15b7f6…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	92d9a9d1-76c0-4435-984d-48f44b452855	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214443 application number: ANDA214443
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	b3b9dcf4-cada-4f79-befc-319c7dff15eb	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214443 application number: ANDA214443
Allopurinol	ALLOPURINOL	Coupler LLC	47b8c920-4648-604e-e063-6294a90a1f54	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214443 application number: ANDA214443
Allopurinol	ALLOPURINOL	ST. MARY'S MEDICAL PARK PHARMACY	42de3b18-a289-e49e-e063-6394a90a89d4	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214443 application number: ANDA214443
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	3f0134bf-b62f-1077-e063-6394a90a60b0	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214443 application number: ANDA214443
Allopurinol	ALLOPURINOL	NuCare Pharmaceuticals, Inc.	2f27f578-f965-04c9-e063-6394a90a1ae2	2025-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214443 application number: ANDA214443
Allopurinol	ALLOPURINOL	Harman Finochem Limited	0780dc78-d287-d5db-e063-6294a90aa1dd	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214443 application number: ANDA214443
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	92253e70-0b0c-4a0c-9bd6-ccea91000819	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214443 application number: ANDA214443
Allopurinol	ALLOPURINOL	NuCare Pharmaceuticals, Inc.	20eef55e-0d70-874b-e063-6394a90aa06a	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214443 application number: ANDA214443

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66064-1043	Allopurinol	Allopurinol	Harman Finochem Limited	ANDA	Current
66064-1044	Allopurinol	Allopurinol	Harman Finochem Limited	ANDA	Current