Application 214581

Type: NDA
Sponsor: NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	TABLET; ORAL	200MG	Yes	No
002	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE	TABLET; ORAL	300MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214581-001	SOVUNA	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL		RLD	2022-01-14
N214581-002	SOVUNA	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL		RLD, RS	2022-01-14

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 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214581-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	RLD	2022-01-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214581-002	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214581-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	RLD	2022-01-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214581-002	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214581-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	RLD	2022-01-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214581-002	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214581-001	HYDROXYCHLOROQUINE SULFATE	200MG	TABLET / ORAL	RLD	2022-01-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N214581-002	HYDROXYCHLOROQUINE SULFATE	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214581-001	SOVUNA	200MG	TABLET / ORAL	RLD	2022-01-14	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N214581-002	SOVUNA	300MG	TABLET / ORAL	RLD, RS	2022-01-14	`1c564ffb4f44…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOVUNA	HYDROXYCHLOROQUINE SULFATE	ANI Pharmaceuticals, Inc.	dd441154-b196-4d4c-bc56-2e37f345ef8d	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214581 application number: NDA214581

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70954-171	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Novitium Pharma LLC	NDA	Current
70954-171	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Novitium Pharma LLC	NDA	Current
70954-171	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Novitium Pharma LLC	NDA	Current
70954-172	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Novitium Pharma LLC	NDA	Current
70954-172	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Novitium Pharma LLC	NDA	Current
70954-172	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate	Novitium Pharma LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79858	SUPPL	2024-10-11
75490	SUPPL	2023-09-15
75470	SUPPL	2023-09-15
74892	SUPPL	2023-07-26
74883	SUPPL	2023-07-25
73155	SUPPL	2023-01-13
73153	SUPPL	2023-01-13
72403	ORIG	2022-10-17
69932	ORIG	2022-01-20
69900	ORIG	2022-01-19