Application 040766

Type: ANDA
Sponsor: IPCA LABS LTD

Application Products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040766-001	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2007-06-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040766-001	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	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040766-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-06-14	`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	A040766-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040766-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040766-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040766-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040766-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040766-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040766-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040766-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040766-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040766-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040766-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040766-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040766-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040766-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040766-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040766-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040766-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040766-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040766-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040766-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040766-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040766-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040766-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040766-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040766-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040766-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040766-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040766-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040766-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040766-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040766-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040766-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040766-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040766-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040766-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040766-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040766-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040766-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040766-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040766-001	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
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Bryant Ranch Prepack	37413f6b-fb68-4e0c-8bcc-c5b76e956dfc	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040766 application number: ANDA040766
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Coupler LLC	2eeaf562-95f9-bcef-e063-6394a90a1c19	2025-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040766 application number: ANDA040766
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Ipca Laboratories Limited	9dfa0ff8-e8cf-47f9-847a-b86f23dc39df	2024-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040766 application number: ANDA040766

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
10544-578	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Blenheim Pharmacal, Inc.	ANDA	Current
21695-486	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Rebel Distributors Corp	ANDA	Current
33261-933	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Aidarex Pharmaceuticals LLC	ANDA	Current
43353-972	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-0681	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	A-S Medication Solutions	ANDA	Current
51660-296	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Ohm Laboratories Inc.	ANDA	Current
53808-1112	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	DOH CENTRAL PHARMACY	ANDA	Current
63304-296	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
66336-555	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Dispensing Solutions, Inc.	ANDA	Current
76385-144	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-144	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-144	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Bayshore Pharmaceuticals LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62495	SUPPL	2020-04-08
62494	SUPPL	2020-04-08