Application 009768

Type: NDA
Sponsor: CONCORDIA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PLAQUENIL	HYDROXYCHLOROQUINE SULFATE	TABLET;ORAL	200MG	Yes	Yes

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
N009768-001	PLAQUENIL	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N009768-001	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N009768-001	PLAQUENIL	200MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`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	N009768-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009768-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009768-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009768-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009768-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009768-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009768-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009768-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009768-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009768-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009768-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009768-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009768-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N009768-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009768-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N009768-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N009768-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N009768-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N009768-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N009768-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N009768-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N009768-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N009768-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N009768-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N009768-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N009768-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N009768-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N009768-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N009768-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N009768-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N009768-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N009768-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N009768-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N009768-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N009768-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N009768-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N009768-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N009768-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N009768-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N009768-001	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
Plaquenil	HYDROXYCHLOROQUINE SULFATE	Advanz Pharma (US) Corp.	34496b43-05a2-45fb-a769-52b12e099341	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009768 application number: NDA009768 ndc (product): 59212-562
Plaquenil	HYDROXYCHLOROQUINE SULFATE	Aphena Pharma Solutions - Tennessee, LLC	eb26c050-fc41-4183-9f8c-86351335fa64	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009768 application number: NDA009768 ndc (product): 71610-473
Plaquenil	HYDROXYCHLOROQUINE SULFATE	Proficient Rx LP	8aec894d-5711-4079-b167-240713bf04f2	2020-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009768 application number: NDA009768 ndc (product): 71205-448

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-335	Plaquenil	Hydroxychloroquine Sulfate	AvKARE, Inc.	NDA	Current
43353-051	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
43353-051	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
43353-997	Plaquenil	Hydroxychloroquine Sulfate	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
50090-3432	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
59212-562	Plaquenil	Hydroxychloroquine Sulfate	Concordia Pharmaceuticals Inc.	NDA	Current
59212-562	Plaquenil	Hydroxychloroquine Sulfate	Concordia Pharmaceuticals Inc.	NDA	Current
59212-562	Plaquenil	Hydroxychloroquine Sulfate	Concordia Pharmaceuticals Inc.	NDA	Current
59212-562	Plaquenil	Hydroxychloroquine Sulfate	Concordia Pharmaceuticals Inc.	NDA	Current
59212-562	Plaquenil	Hydroxychloroquine Sulfate	Concordia Pharmaceuticals Inc.	NDA	Current
59212-562	Plaquenil	Hydroxychloroquine Sulfate	Concordia Pharmaceuticals Inc.	NDA	Current
63629-3343	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-3343	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-3343	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
66993-057	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-057	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-057	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-057	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-057	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
67296-1781	Plaquenil	Hydroxychloroquine Sulfate	RedPharm Drug, Inc.	NDA	Current
67296-1781	Plaquenil	Hydroxychloroquine Sulfate	RedPharm Drug, Inc.	NDA	Current
68151-0511	Plaquenil	Hydroxychloroquine Sulfate	Carilion Materials Management	NDA	Current
68788-7770	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Preferred Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68788-7770	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Preferred Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
71205-448	Plaquenil	Hydroxychloroquine Sulfate	Proficient Rx LP	NDA	Current
71610-473	Plaquenil	Hydroxychloroquine Sulfate	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
71610-473	Plaquenil	Hydroxychloroquine Sulfate	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76787	SUPPL	2023-12-13
76777	SUPPL	2023-12-13
74891	SUPPL	2023-07-26
74887	SUPPL	2023-07-25
70985	SUPPL	2022-05-04
70979	SUPPL	2022-05-04
67437	SUPPL	2021-05-07
67399	SUPPL	2021-05-04
59358	SUPPL	2019-07-16
59357	SUPPL	2019-07-16
47021	SUPPL	2017-01-30
47020	SUPPL	2017-01-30
47019	SUPPL	2017-01-30
47027	SUPPL	2017-01-27
47026	SUPPL	2017-01-27
47025	SUPPL	2017-01-27
11881	SUPPL	2007-07-05
33006	SUPPL	2007-06-27