Application 210117

Type: ANDA
Sponsor: ZYDUS 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
003	ALLOPURINOL	ALLOPURINOL	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A210117-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12
A210117-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12
A210117-003	ALLOPURINOL	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-06-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210117-001	AB
A210117-002	AB
A210117-003	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 3 · 89 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	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210117-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-06-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210117-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210117-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210117-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210117-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2017-10-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210117-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2017-10-12	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 89 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	A210117-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210117-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210117-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210117-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210117-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210117-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210117-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210117-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210117-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210117-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210117-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210117-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210117-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210117-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210117-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210117-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210117-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210117-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210117-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210117-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210117-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210117-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210117-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210117-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210117-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210117-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210117-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210117-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210117-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210117-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210117-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210117-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210117-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210117-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210117-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210117-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210117-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210117-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210117-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210117-002	AB	1	`4b0b4de00fa7…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Major Pharmaceuticals	b630c1cb-d4b7-4f80-b252-5947c1887def	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210117 application number: ANDA210117 ndc (product): 0904-7041
Allopurinol	ALLOPURINOL	Cardinal Health 107, LLC	2462b4b5-8313-4e4d-93ac-839de4a29520	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210117 application number: ANDA210117 ndc (product): 55154-2338
Allopurinol	ALLOPURINOL	Zydus Lifesciences Limited	9232f484-a5f6-4c63-b7f4-b510d2827159	2025-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210117 application number: ANDA210117 ndc (product): 70771-1126 ndc (product): 70771-1127
Allopurinol	ALLOPURINOL	Zydus Pharmaceuticals (USA) Inc.	8b926e62-3a9c-424a-833a-8169e55a1f15	2025-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210117 application number: ANDA210117 ndc (product): 70710-1209 ndc (product): 70710-1210

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7041	Allopurinol	Allopurinol	Major Pharmaceuticals	ANDA	Current
0904-7041	Allopurinol	Allopurinol	Major Pharmaceuticals	ANDA	Current
55154-2338	Allopurinol	Allopurinol	Cardinal Health	ANDA	Current
55154-2338	Allopurinol	Allopurinol	Cardinal Health 107, LLC	ANDA	Current
68788-7542	Allopurinol	Allopurinol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7542	Allopurinol	Allopurinol	Preferred Pharmaceuticals, Inc.	ANDA	Current
70710-1209	Allopurinol	Allopurinol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1209	Allopurinol	Allopurinol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1209	Allopurinol	Allopurinol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1210	Allopurinol	Allopurinol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1210	Allopurinol	Allopurinol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1210	Allopurinol	Allopurinol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1126	Allopurinol	Allopurinol	Zydus Lifesciences Limited	ANDA	Current
70771-1126	Allopurinol	Allopurinol	Cadila Healthcare Limited	ANDA	Current
70771-1126	Allopurinol	Allopurinol	Cadila Healthcare Limited	ANDA	Current
70771-1127	Allopurinol	Allopurinol	Zydus Lifesciences Limited	ANDA	Current
70771-1127	Allopurinol	Allopurinol	Cadila Healthcare Limited	ANDA	Current
70771-1127	Allopurinol	Allopurinol	Cadila Healthcare Limited	ANDA	Current