Application 071587

Type: ANDA
Sponsor: DR REDDYS LA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOPURIN	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071587-001	LOPURIN	ALLOPURINOL	300MG	TABLET / ORAL	AB		1987-04-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071587-001	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 · 41 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	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071587-001	LOPURIN	300MG	TABLET / ORAL	AB	1987-04-02	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A071587-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071587-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071587-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071587-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071587-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071587-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071587-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071587-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071587-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071587-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071587-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071587-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071587-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071587-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071587-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071587-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071587-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071587-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071587-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071587-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071587-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071587-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071587-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071587-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071587-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071587-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071587-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071587-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071587-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071587-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071587-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071587-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071587-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071587-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071587-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071587-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071587-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071587-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071587-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071587-001	AB	1	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Northwind Health Company, LLC	da814597-50e6-48fa-e053-2995a90ab21b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071587 application number: ANDA071587
Allopurinol	ALLOPURINOL	Dr. Reddy's Laboratories Limited	19a138b8-d225-03e6-f762-abe71560204b	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071587 application number: ANDA071587 ndc (product): 55111-730
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	278df77c-3a9c-4c7d-ba8f-eb33f6335ef4	2022-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071587 application number: ANDA071587 ndc (product): 71610-064

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-911	Allopurinol	Allopurinol	Blenheim Pharmacal, Inc.	ANDA	Current
43353-088	Allopurinol	Allopurinol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-088	Allopurinol	Allopurinol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
55111-730	Allopurinol	Allopurinol	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-730	Allopurinol	Allopurinol	Dr. Reddy's Laboratories Limited	ANDA	Current
60429-181	Allopurinol	Allopurinol	Golden State Medical Supply, Inc.	ANDA	Current
68788-0603	Allopurinol	Allopurinol	Preferred Pharmaceuticals, Inc.	ANDA	Current
71610-064	Allopurinol	Allopurinol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-064	Allopurinol	Allopurinol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current