Application 040133

Type: ANDA
Sponsor: WATSON LABS

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 43.

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
A040133-001	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL			1995-11-30

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 · 43 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
2026-09-14 22:38:34	2026-08	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		1995-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040133-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	1995-11-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040133-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040133-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040133-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040133-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040133-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040133-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040133-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040133-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040133-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040133-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040133-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040133-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040133-001	AB	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040133-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040133-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040133-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040133-001	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 3 of 3 · 49 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Laurus Labs Limited	04d8fdbf-8829-4469-a341-8af2a2d91ccc	2024-01-05	Warnings, Adverse reactions	Name fallback brand name: HYDROXYCHLOROQUINE SULFATE generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Northstar Rx LLC.	29ba0172-7ca3-4122-af1b-f0da522318cb	2023-12-22	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Quallent Pharmaceuticals Health LLC	81e68f23-b1bf-4561-8f02-a472631acfaf	2023-12-21	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Zydus Pharmaceuticals USA Inc.	805a1acd-2e0d-48f1-af6b-0e5d8e06c228	2023-12-19	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	A-S Medication Solutions	b4dca05a-745f-4c15-b731-1e99176cf44c	2023-10-31	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine Sulfate generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Aphena Pharma Solutions - Tennessee, LLC	beff29fe-574f-4566-99ac-53ec3b3038a7	2023-05-01	Warnings, Adverse reactions	Name fallback brand name: HYDROXYCHLOROQUINE SULFATE generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Sun Pharmaceutical Industries, Inc.	6e72fe06-7995-3fd7-e053-2a91aa0a54db	2022-11-11	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Aphena Pharma Solutions - Tennessee, LLC	90111c26-cd12-4a45-a25f-8d83c83c80de	2020-12-22	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Plaquenil	HYDROXYCHLOROQUINE SULFATE	Proficient Rx LP	8aec894d-5711-4079-b167-240713bf04f2	2020-04-01	Warnings, Adverse reactions	Name fallback generic name: HYDROXYCHLOROQUINE SULFATE

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-3041	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Actavis Pharma, Inc.	ANDA	Current
0591-3041	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Actavis Pharma, Inc.	ANDA	Current
0591-3041	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Actavis Pharma, Inc.	ANDA	Current
0591-3041	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Actavis Pharma, Inc.	ANDA	Current
0591-3041	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Actavis Pharma, Inc.	ANDA	Current
0591-3041	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Actavis Pharma, Inc.	ANDA	Current
0591-3041	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Actavis Pharma, Inc.	ANDA	Current
0591-3041	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Actavis Pharma, Inc.	ANDA	Current
0615-8325	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8325	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8325	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43353-794	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-2508	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	A-S Medication Solutions	ANDA	Current
50090-2508	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	A-S Medication Solutions	ANDA	Current
50090-2508	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	A-S Medication Solutions	ANDA	Current
50090-2508	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	A-S Medication Solutions	ANDA	Current
53002-4850	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-4850	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	RPK Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62487	SUPPL	2020-04-08
62486	SUPPL	2020-04-08
62485	SUPPL	2020-04-08
62484	SUPPL	2020-04-08