Application 208635

Type: ANDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	INJECTABLE;INJECTION	25MG/ML	No	No

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
A208635-001	SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION			2017-05-04

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2017-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2017-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2017-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2017-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2017-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2017-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2017-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2017-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2017-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2017-05-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2017-05-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2017-05-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2017-05-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208635-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION		2017-05-04	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208635-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208635-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208635-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208635-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208635-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208635-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208635-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208635-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208635-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208635-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208635-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208635-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208635-001	AP	1	`ea99ee380514…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Nitroprusside	SODIUM NITROPRUSSIDE	Somerset Therapeutics, LLC	2122b9c1-0af4-493b-82cc-63eee02f987f	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sodium Nitroprusside generic name: SODIUM NITROPRUSSIDE
Sodium nitroprusside	SODIUM NITROPRUSSIDE	Mylan Institutional LLC	6fbfb86c-da8d-4741-b1e0-7000e2bbad5f	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sodium nitroprusside generic name: SODIUM NITROPRUSSIDE
Sodium Nitroprusside	SODIUM NITROPRUSSIDE	Dr.Reddy's Laboratories Inc.,	a3b83d0e-b8f7-5e90-c363-1edfcd27a33d	2025-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sodium Nitroprusside generic name: SODIUM NITROPRUSSIDE
Sodium Nitroprusside	SODIUM NITROPRUSSIDE	Caplin Steriles Limited	a8c5d04b-c6cb-46e6-b90c-e858a0a52406	2025-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sodium Nitroprusside generic name: SODIUM NITROPRUSSIDE
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	Micro Labs Limited	5a599880-c133-44ef-a9f2-bd1b681563be	2025-02-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SODIUM NITROPRUSSIDE generic name: SODIUM NITROPRUSSIDE
Sodium Nitroprusside	SODIUM NITROPRUSSIDE	Dr.Reddy's Laboratories Inc.,	5a689f89-3cbd-f9fa-13cc-26063feb9c83	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sodium Nitroprusside generic name: SODIUM NITROPRUSSIDE
Sodium Nitroprusside	SODIUM NITROPRUSSIDE	Meitheal Pharmaceuticals Inc.	820eadcb-1230-4b17-a652-e69b52b3c12f	2024-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sodium Nitroprusside generic name: SODIUM NITROPRUSSIDE
sodium nitroprusside	SODIUM NITROPRUSSIDE	Hainan Poly Pharm. Co., Ltd.	1f875445-f8e4-b097-e063-6294a90ad544	2024-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: sodium nitroprusside generic name: SODIUM NITROPRUSSIDE
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	Armas Pharmaceuticals Inc.	d3f1276a-5944-48e3-8ff1-19995ffb7ef9	2023-07-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SODIUM NITROPRUSSIDE generic name: SODIUM NITROPRUSSIDE
Sodium Nitroprusside	SODIUM NITROPRUSSIDE	Hainan Poly Pharm. Co., Ltd.	72a9b7df-3a2f-4c16-93a9-b645bc0e8143	2022-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sodium Nitroprusside generic name: SODIUM NITROPRUSSIDE
Sodium Nitroprusside	SODIUM NITROPRUSSIDE	BE Pharmaceuticals Inc.	01841345-bed3-458f-8e99-911fbd286512	2021-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sodium Nitroprusside generic name: SODIUM NITROPRUSSIDE
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	AuroMedics Pharma LLC	41e11afb-5fa4-4212-889d-1092dbd0702a	2020-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SODIUM NITROPRUSSIDE generic name: SODIUM NITROPRUSSIDE
sodium nitroprusside	SODIUM NITROPRUSSIDE	Slate Run Pharmaceuticals, LLC	01dfae56-3d9b-448a-84a7-03a54a533eb1	2020-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: sodium nitroprusside generic name: SODIUM NITROPRUSSIDE
Sodium nitroprusside	SODIUM NITROPRUSSIDE	Mylan Institutional LLC	a8999285-16b1-473d-8e92-684f581534f6	2020-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sodium nitroprusside generic name: SODIUM NITROPRUSSIDE
Sodium nitroprusside	SODIUM NITROPRUSSIDE	Amneal Pharmaceuticals LLC	2fa687a2-10e7-45ae-953a-9d63564c2908	2019-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sodium nitroprusside generic name: SODIUM NITROPRUSSIDE
NIPRIDE RTU	SODIUM NITROPRUSSIDE	EXELA PHARMA SCIENCES, LLC	5acf0836-93ff-4064-b888-3f560e8a558d	2018-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SODIUM NITROPRUSSIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-014	Sodium Nitroprusside	Sodium Nitroprusside	Akorn	ANDA	Current
17478-014	Sodium Nitroprusside	Sodium Nitroprusside	Akorn, Inc.	ANDA	Current
17478-014	Sodium Nitroprusside	Sodium Nitroprusside	Akorn, Inc.	ANDA	Current