Application 213342

Type: ANDA
Sponsor: ACCORD HLTHCARE

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
002	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	TABLET;ORAL	100MG	No	No
003	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	TABLET;ORAL	300MG	No	No
004	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	TABLET;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213342-001	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07
A213342-002	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18
A213342-003	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18
A213342-004	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A213342-001	AB
A213342-002	AB
A213342-003	AB
A213342-004	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 4 · 140 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
2026-08-18 06:07:40	2026-07	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213342-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB		2020-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213342-002	HYDROXYCHLOROQUINE SULFATE	100MG	TABLET / ORAL	AB		2021-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213342-003	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	AB		2021-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213342-004	HYDROXYCHLOROQUINE SULFATE	400MG	TABLET / ORAL	AB	RS	2021-08-18	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 119 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213342-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213342-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213342-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213342-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213342-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213342-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213342-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213342-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213342-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213342-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213342-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213342-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213342-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213342-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213342-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213342-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213342-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213342-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213342-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213342-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213342-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213342-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213342-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213342-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213342-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213342-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213342-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213342-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213342-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213342-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213342-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213342-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213342-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213342-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213342-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213342-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213342-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213342-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213342-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213342-004	AB	1	`d8e5a09893c0…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	Accord Healthcare, Inc.,	84b00366-96ef-41e1-bac6-5d24acdb9e1d	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213342 application number: ANDA213342 ndc (product): 16729-561 ndc (product): 16729-562 ndc (product): 16729-485 ndc (product): 16729-563
Hydroxychloroquine Sulfate	HYDROXYCHLOROQUINE SULFATE	A-S Medication Solutions	b4dca05a-745f-4c15-b731-1e99176cf44c	2023-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213342 application number: ANDA213342 ndc (product): 50090-6280

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8401	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8401	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
16729-485	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Accord Healthcare, Inc.	ANDA	Current
16729-485	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Accord Healthcare, Inc.	ANDA	Current
16729-485	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Accord Healthcare, Inc.,	ANDA	Current
16729-485	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Accord Healthcare, Inc.,	ANDA	Current
16729-561	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Accord Healthcare, Inc.,	ANDA	Current
16729-562	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Accord Healthcare, Inc.,	ANDA	Current
16729-563	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Accord Healthcare, Inc.,	ANDA	Current
50090-6280	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	A-S Medication Solutions	ANDA	Current