Application 040760

Type: ANDA
Sponsor: HIKMA PHARMS

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
A040760-001	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL			2007-08-15

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	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-08-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-08-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	2007-08-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040760-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A040760-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040760-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040760-001	AB	1	`ea99ee380514…`

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 2 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	Bryant Ranch Prepack	84957919-ca14-4c3d-b4fe-452ff330dd7a	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: HYDROXYCHLOROQUINE SULFATE generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	NuCare Pharmaceuticals,Inc.	b8e3a352-a1e3-e672-e053-2a95a90a641c	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	A-S Medication Solutions	6a06ad3d-2d6c-4e51-93f5-8f782b86975b	2025-05-09	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine sulfate generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Aurobindo Pharma Limited	e6f889ff-c5ba-4324-b87c-ec3ac942be2f	2025-03-11	Warnings, Adverse reactions	Name fallback brand name: HYDROXYCHLOROQUINE SULFATE generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Coupler LLC	2eeaf562-95f9-bcef-e063-6394a90a1c19	2025-02-24	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine Sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Ipca Laboratories Limited	9dfa0ff8-e8cf-47f9-847a-b86f23dc39df	2024-11-19	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine Sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	A-S Medication Solutions	3817387f-2fc8-4f39-8096-3b48fff57ab0	2024-10-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	A-S Medication Solutions	53553ef5-5f44-4d39-ae8c-c9a632cc8416	2024-10-15	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine sulfate generic name: HYDROXYCHLOROQUINE SULFATE
SOVUNA	HYDROXYCHLOROQUINE SULFATE	ANI Pharmaceuticals, Inc.	dd441154-b196-4d4c-bc56-2e37f345ef8d	2024-10-08	Warnings, Adverse reactions	Name fallback generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Asclemed USA, Inc.	19816051-c25e-44b5-a127-e846dbd0a8d8	2024-09-05	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine sulfate generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Bryant Ranch Prepack	2c109188-d28b-4c65-8b52-819bd8547f2e	2024-08-16	Warnings, Adverse reactions	Name fallback brand name: HYDROXYCHLOROQUINE SULFATE generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	American Health Packaging	a2d7be5a-98ee-4292-8715-46573dbe1c5b	2024-08-01	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine Sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Bryant Ranch Prepack	f618a091-ade1-4c39-ab76-f6218b606e05	2024-07-09	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	NCS HealthCare of KY, LLC dba Vangard Labs	83cb17e9-ce57-48aa-b92c-ac0dee92d5bc	2024-06-21	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Amneal Pharmaceuticals NY LLC	6a9e2fc8-bedf-46d4-9973-328dbcb18061	2024-06-11	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine Sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	A-S Medication Solutions	1a1fb21d-a01c-4d50-8764-cdd6c20d9569	2024-05-30	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Rising Pharma Holdings, Inc.	6837f2aa-1349-4b45-a0ac-09ec914fd764	2024-05-06	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine Sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Bryant Ranch Prepack	cf4b1912-9806-4ef3-bf17-152a96d75bbc	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine Sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Plaquenil	HYDROXYCHLOROQUINE SULFATE	Aphena Pharma Solutions - Tennessee, LLC	eb26c050-fc41-4183-9f8c-86351335fa64	2024-04-04	Warnings, Adverse reactions	Name fallback generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Teva Pharmaceuticals USA, Inc.	5f3e49b2-dc11-40a9-b366-c88e36a471e5	2024-02-29	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine Sulfate 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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-2128	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	West-ward Pharmaceutical Corp	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62493	SUPPL	2020-04-08
62492	SUPPL	2020-04-08