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 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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040760-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		2007-08-15	`cb3db0bc1861…`

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 1 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	da435181-0c5a-4188-8d59-51234116b005	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine Sulfate generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Bryant Ranch Prepack	68d6439d-b927-47e6-86ef-20e572e81941	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: HYDROXYCHLOROQUINE SULFATE generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Cardinal Health 107, LLC	e5fe2ece-40a1-49eb-818f-62ff3c3bb199	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: HYDROXYCHLOROQUINE SULFATE generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Cardinal Health 107, LLC	6971241c-8323-456e-91a4-a404a9e100de	2026-05-18	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Preferred Pharmaceuticals, Inc.	d6c8ee2e-116e-4167-8d1a-bd570a1ce672	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Plaquenil	HYDROXYCHLOROQUINE SULFATE	Advanz Pharma (US) Corp.	34496b43-05a2-45fb-a769-52b12e099341	2026-04-09	Warnings, Adverse reactions	Name fallback generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Accord Healthcare, Inc.,	84b00366-96ef-41e1-bac6-5d24acdb9e1d	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine Sulfate generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Bryant Ranch Prepack	1a39c45e-dc14-4441-9b02-7329647bc5a4	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: HYDROXYCHLOROQUINE SULFATE generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Bryant Ranch Prepack	517ee47b-6abf-43cb-a4ca-c2e7827461a8	2026-03-16	Warnings, Adverse reactions	Name fallback brand name: HYDROXYCHLOROQUINE SULFATE generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	A-S Medication Solutions	87076a61-ce76-475b-ac6d-c33ba617195d	2026-02-14	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine Sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Bryant Ranch Prepack	37413f6b-fb68-4e0c-8bcc-c5b76e956dfc	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine Sulfate generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	NuCare Pharmaceuticals, Inc.	4902343c-7d1b-ba70-e063-6294a90a3680	2026-01-22	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine sulfate generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	AvPAK	a5b3455a-e842-7d4b-e053-2995a90adee3	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: HYDROXYCHLOROQUINE SULFATE generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Amneal Pharmaceuticals NY LLC	7804f5d2-41a6-4523-a277-6967e984e88e	2025-12-22	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine Sulfate generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Dr. Reddy's Laboratories Inc.	452092b4-7a8f-4d19-8113-f1c2a948d3d8	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: HYDROXYCHLOROQUINE SULFATE generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Major Pharmaceuticals	ebe00e35-ed3d-40f4-9a93-a37b0da01ddb	2025-11-10	Warnings, Adverse reactions	Name fallback brand name: HYDROXYCHLOROQUINE SULFATE generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Aphena Pharma Solutions - Tennessee, LLC	427ac2fc-8f7f-9725-e063-6394a90a381b	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Hydroxychloroquine Sulfate generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Creekwood Pharmaceuticals LLC	04139607-f7c0-4fe1-a210-ffa5af347d56	2025-10-09	Warnings, Adverse reactions	Name fallback brand name: HYDROXYCHLOROQUINE SULFATE generic name: HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine sulfate	HYDROXYCHLOROQUINE SULFATE	Zydus Lifesciences Limited	1aa44bff-9a62-48b4-a520-98d7d524e3a9	2025-10-04		Name fallback brand name: Hydroxychloroquine sulfate generic name: HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	Bryant Ranch Prepack	f95cfc03-5023-44b3-8994-25afac18b734	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: HYDROXYCHLOROQUINE SULFATE generic name: HYDROXYCHLOROQUINE SULFATE

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