Application 210607

Type: NDA
Sponsor: 60 DEGREES PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARAKODA	TAFENOQUINE SUCCINATE	TABLET;ORAL	EQ 100MG BASE	Yes	Yes

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
N210607-001	ARAKODA	TAFENOQUINE SUCCINATE	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2018-08-08

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N210607-001	10342791	2035-12-02	U-2582	2019-07-31
N210607-001	10888558	2035-12-02	U-2582	2021-02-10
N210607-001	11744828	2035-12-02	U-2582	2023-10-04
N210607-001	12616689	2035-12-02	U-2582	2026-06-01

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210607-001	ARAKODA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2018-08-08	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 104 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N210607-001	10342791	2035-12-02	U-2582	2019-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210607-001	10888558	2035-12-02	U-2582	2021-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210607-001	11744828	2035-12-02	U-2582	2023-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210607-001	12616689	2035-12-02	U-2582	2026-06-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210607-001	10342791	2035-12-02	U-2582	2019-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210607-001	10888558	2035-12-02	U-2582	2021-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210607-001	11744828	2035-12-02	U-2582	2023-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210607-001	12616689	2035-12-02	U-2582	2026-06-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210607-001	10342791	2035-12-02	U-2582	2019-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210607-001	10888558	2035-12-02	U-2582	2021-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210607-001	11744828	2035-12-02	U-2582	2023-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210607-001	10342791	2035-12-02	U-2582	2019-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210607-001	10888558	2035-12-02	U-2582	2021-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210607-001	11744828	2035-12-02	U-2582	2023-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210607-001	10342791	2035-12-02	U-2582	2019-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210607-001	10888558	2035-12-02	U-2582	2021-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210607-001	11744828	2035-12-02	U-2582	2023-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210607-001	10342791	2035-12-02	U-2582	2019-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210607-001	10888558	2035-12-02	U-2582	2021-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210607-001	11744828	2035-12-02	U-2582	2023-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210607-001	10342791	2035-12-02	U-2582	2019-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210607-001	10888558	2035-12-02	U-2582	2021-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210607-001	11744828	2035-12-02	U-2582	2023-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210607-001	10342791	2035-12-02	U-2582	2019-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210607-001	10888558	2035-12-02	U-2582	2021-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210607-001	11744828	2035-12-02	U-2582	2023-10-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210607-001	10342791	2035-12-02	U-2582	2019-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210607-001	10888558	2035-12-02	U-2582	2021-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210607-001	11744828	2035-12-02	U-2582	2023-10-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210607-001	10342791	2035-12-02	U-2582	2019-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210607-001	10888558	2035-12-02	U-2582	2021-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210607-001	11744828	2035-12-02	U-2582	2023-10-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210607-001	10342791	2035-12-02	U-2582	2019-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210607-001	10888558	2035-12-02	U-2582	2021-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210607-001	11744828	2035-12-02	U-2582	2023-10-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210607-001	10342791	2035-12-02	U-2582	2019-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210607-001	10888558	2035-12-02	U-2582	2021-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210607-001	11744828	2035-12-02	U-2582	2023-10-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210607-001	10342791	2035-12-02	U-2582	2019-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210607-001	10888558	2035-12-02	U-2582	2021-02-10	`79d66fd596c7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210607-001	NCE	2023-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210607-001	NCE	2023-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210607-001	NCE	2023-07-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210607-001	NP	2021-08-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210607-001	NCE	2023-07-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210607-001	NCE	2023-07-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210607-001	NP	2021-08-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210607-001	NCE	2023-07-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210607-001	NP	2021-08-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210607-001	NCE	2023-07-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210607-001	NP	2021-08-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210607-001	NCE	2023-07-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210607-001	NP	2021-08-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210607-001	NCE	2023-07-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210607-001	NP	2021-08-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210607-001	NCE	2023-07-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210607-001	NP	2021-08-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N210607-001	NCE	2023-07-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210607-001	NP	2021-08-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N210607-001	NCE	2023-07-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210607-001	NP	2021-08-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N210607-001	NCE	2023-07-20	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N210607-001	NCE	2023-07-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210607-001	NCE	2023-07-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210607-001	NCE	2023-07-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210607-001	NCE	2023-07-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210607-001	NCE	2023-07-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210607-001	NCE	2023-07-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210607-001	NCE	2023-07-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210607-001	NCE	2023-07-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210607-001	NCE	2023-07-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210607-001	NCE	2023-07-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210607-001	NCE	2023-07-20	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arakoda	TAFENOQUINE	60 Degrees Pharmaceuticals, INC.	299e49d8-470f-4779-a010-4a1ee0e0c6cd	2025-01-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210607 application number: NDA210607 ndc (product): 71475-257

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71475-257	Arakoda	Tafenoquine	60 Degrees Pharmaceuticals, LLC	NDA	Current
71475-257	Arakoda	Tafenoquine	60 Degrees Pharmaceuticals, LLC	NDA	Current
71475-257	Arakoda	Tafenoquine	60 Degrees Pharmaceuticals, LLC	NDA	Current
71475-257	Arakoda	Tafenoquine	60 Degrees Pharmaceuticals, LLC	NDA	Current
71475-257	Arakoda	Tafenoquine	60 Degrees Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57584	ORIG	2019-02-13
55162	ORIG	2018-08-10
55138	ORIG	2018-08-08