Application 211016

Type: ANDA
Sponsor: CAPLIN

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
A211016-001	SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP		2019-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211016-001	AP

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211016-001	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE / INJECTION	AP	2019-11-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211016-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211016-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211016-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211016-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211016-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211016-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211016-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211016-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211016-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211016-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211016-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211016-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211016-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211016-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211016-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211016-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211016-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211016-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211016-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211016-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211016-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211016-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211016-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211016-001	AP	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211016-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211016-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211016-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211016-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211016-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211016-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211016-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211016-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211016-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211016-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211016-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211016-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211016-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211016-001	AP	1	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Nitroprusside	SODIUM NITROPRUSSIDE	Caplin Steriles Limited	a8c5d04b-c6cb-46e6-b90c-e858a0a52406	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211016 application number: ANDA211016 ndc (product): 65145-101
Sodium Nitroprusside	SODIUM NITROPRUSSIDE	Meitheal Pharmaceuticals Inc.	820eadcb-1230-4b17-a652-e69b52b3c12f	2024-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211016 application number: ANDA211016 ndc (product): 71288-202

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65145-101	Sodium Nitroprusside	Sodium Nitroprusside	Caplin Steriles Limited	ANDA	Current
71288-202	Sodium Nitroprusside	Sodium Nitroprusside	Meitheal Pharmaceuticals Inc.	ANDA	Current