Application 211820

Type: ANDA
Sponsor: UNICHEM LABS LTD

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
A211820-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12
A211820-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211820-001	AB
A211820-002	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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2019-03-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2019-03-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2019-03-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2019-03-12	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A211820-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211820-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211820-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211820-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211820-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211820-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211820-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A211820-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211820-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211820-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211820-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211820-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211820-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211820-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211820-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A211820-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211820-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A211820-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211820-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211820-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211820-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211820-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211820-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211820-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211820-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211820-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211820-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211820-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211820-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211820-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211820-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211820-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211820-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A211820-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211820-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A211820-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211820-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211820-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211820-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A211820-002	AB	1	`f41ea6bd6efb…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	REMEDYREPACK INC.	36526c80-5a70-47c4-a0a6-785ccc346703	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	REMEDYREPACK INC.	5ffcbc32-5996-41cd-acdc-cc4af8cdaf4f	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	St. Mary's Medical Park Pharmacy	00b27899-e68f-e9d9-e063-6394a90a88cb	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	1f626471-153c-4740-8019-9089ea741684	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	8ae2d634-df53-40a8-a6bd-6fee7dacd754	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	Direct_Rx	f6c83ee9-c07b-9fc8-e053-6394a90a2160	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	e11e94b9-d897-48ce-9a80-aa6b8b5fde02	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	Unichem Pharmaceuticals (USA), Inc.	e3face45-f920-46a0-b707-6a66aa9735bd	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820 ndc (product): 29300-350 ndc (product): 29300-349
Allopurinol	ALLOPURINOL	A-S Medication Solutions	5efa81be-e2c9-4fb7-bd0d-aeca3920a393	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	A-S Medication Solutions	f26674cd-d2b7-433c-a593-6a52012b81e3	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	American Health Packaging	f6f7642b-5046-47d6-b259-0c9f8aed3b34	2025-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820 ndc (product): 60687-688 ndc (product): 60687-677
Allopurinol	ALLOPURINOL	NuCare Pharmaceuticals,Inc.	faf55184-6962-d49f-e053-6394a90a152e	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	A-S Medication Solutions	3db4e043-71ff-496a-8087-3fde0e352abf	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820 ndc (product): 50090-4662
Allopurinol	ALLOPURINOL	A-S Medication Solutions	2caa5246-9422-4826-b926-a2566506d3eb	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820 ndc (product): 50090-4663

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29300-349	Allopurinol	Allopurinol	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-349	Allopurinol	Allopurinol	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-349	Allopurinol	Allopurinol	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-350	Allopurinol	Allopurinol	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-350	Allopurinol	Allopurinol	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-350	Allopurinol	Allopurinol	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
50090-4662	Allopurinol	Allopurinol	A-S Medication Solutions	ANDA	Current
50090-4662	Allopurinol	Allopurinol	A-S Medication Solutions	ANDA	Current
50090-4663	Allopurinol	Allopurinol	A-S Medication Solutions	ANDA	Current
50090-4663	Allopurinol	Allopurinol	A-S Medication Solutions	ANDA	Current
60687-677	Allopurinol	Allopurinol	American Health Packaging	ANDA	Current
60687-688	Allopurinol	Allopurinol	American Health Packaging	ANDA	Current