Application 212937

Type: NDA
Sponsor: FENNEC PHARMACEUTICALS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEDMARK	SODIUM THIOSULFATE	INJECTABLE;INJECTION	12.5G;100ML	No	No

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

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
N212937-001	PEDMARK	SODIUM THIOSULFATE	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-09-20

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212937-001	10596190	2038-01-05	U-3443	Delist requested	2022-10-06
N212937-001	11291728	2039-07-01		Drug product	2022-10-06
N212937-001	11510984	2039-07-01		Drug product	2022-12-14
N212937-001	11617793	2039-07-01		Drug product	2023-04-17
N212937-001	11964018	2039-07-01	U-3898		2024-05-08
N212937-001	11992530	2039-07-01	U-3948		2024-06-20
N212937-001	11998604	2039-07-01	U-3952		2024-06-24

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212937-001	ODE-384	2029-09-20

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212937-001	PEDMARK	12.5GM/100ML (125MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-09-20	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N212937-001	10596190	2038-01-05	U-3443	Delist requested	2022-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212937-001	11291728	2039-07-01		Drug product	2022-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212937-001	11510984	2039-07-01		Drug product	2022-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212937-001	11617793	2039-07-01		Drug product	2023-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212937-001	11964018	2039-07-01	U-3898		2024-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212937-001	11992530	2039-07-01	U-3948		2024-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212937-001	11998604	2039-07-01	U-3952		2024-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212937-001	10596190	2038-01-05	U-3443	Delist requested	2022-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212937-001	11291728	2039-07-01		Drug product	2022-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212937-001	11510984	2039-07-01		Drug product	2022-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212937-001	11617793	2039-07-01		Drug product	2023-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212937-001	11964018	2039-07-01	U-3898		2024-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212937-001	11992530	2039-07-01	U-3948		2024-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212937-001	11998604	2039-07-01	U-3952		2024-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212937-001	10596190	2038-01-05	U-3443	Delist requested	2022-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212937-001	11291728	2039-07-01		Drug product	2022-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212937-001	11510984	2039-07-01		Drug product	2022-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212937-001	11617793	2039-07-01		Drug product	2023-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212937-001	11964018	2039-07-01	U-3898		2024-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212937-001	11992530	2039-07-01	U-3948		2024-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212937-001	11998604	2039-07-01	U-3952		2024-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212937-001	10596190	2038-01-05	U-3443	Delist requested	2022-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212937-001	11291728	2039-07-01		Drug product	2022-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212937-001	11510984	2039-07-01		Drug product	2022-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212937-001	11617793	2039-07-01		Drug product	2023-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212937-001	11964018	2039-07-01	U-3898		2024-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212937-001	11992530	2039-07-01	U-3948		2024-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212937-001	11998604	2039-07-01	U-3952		2024-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212937-001	10596190	2038-01-05	U-3443	Delist requested	2022-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212937-001	11291728	2039-07-01		Drug product	2022-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212937-001	11510984	2039-07-01		Drug product	2022-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212937-001	11617793	2039-07-01		Drug product	2023-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212937-001	11964018	2039-07-01	U-3898		2024-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212937-001	11992530	2039-07-01	U-3948		2024-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212937-001	11998604	2039-07-01	U-3952		2024-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212937-001	10596190	2038-01-05	U-3443	Delist requested	2022-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212937-001	11291728	2039-07-01		Drug product	2022-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212937-001	11510984	2039-07-01		Drug product	2022-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212937-001	11617793	2039-07-01		Drug product	2023-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212937-001	11964018	2039-07-01	U-3898		2024-05-08	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N212937-001	ODE-384	2029-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212937-001	ODE-384	2029-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212937-001	NP	2025-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212937-001	ODE-384	2029-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212937-001	NP	2025-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212937-001	ODE-384	2029-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212937-001	NP	2025-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212937-001	ODE-384	2029-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212937-001	NP	2025-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212937-001	ODE-384	2029-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212937-001	NP	2025-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212937-001	ODE-384	2029-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212937-001	NP	2025-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212937-001	ODE-384	2029-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212937-001	NP	2025-09-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212937-001	ODE-384	2029-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212937-001	NP	2025-09-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212937-001	ODE-384	2029-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212937-001	NP	2025-09-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212937-001	ODE-384	2029-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212937-001	NP	2025-09-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212937-001	ODE-384	2029-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212937-001	NP	2025-09-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212937-001	ODE-384	2029-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212937-001	NP	2025-09-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212937-001	ODE-384	2029-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212937-001	NP	2025-09-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212937-001	ODE-384	2029-09-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212937-001	NP	2025-09-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212937-001	ODE-384	2029-09-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212937-001	NP	2025-09-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N212937-001	ODE-384	2029-09-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212937-001	NP	2025-09-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N212937-001	ODE-384	2029-09-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212937-001	NP	2025-09-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212937-001	ODE-384	2029-09-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212937-001	NP	2025-09-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212937-001	ODE-384	2029-09-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212937-001	NP	2025-09-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212937-001	ODE-384	2029-09-20	`a67488948f0b…`

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
PEDMARK	SODIUM THIOSULFATE	Fennec Pharmaceuticals Inc.	f98c7076-2a7b-4fd7-ab90-eed5e9137bae	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212937 application number: NDA212937 ndc (product): 73077-010

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
73077-010	PEDMARK	SODIUM THIOSULFATE	Fennec Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74414	ORIG	2023-05-31
72120	ORIG	2022-09-21
72117	ORIG	2022-09-20