Home Applications 203922 Application 203922
Type NDA
Sponsor HOPE PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SODIUM NITRITE SODIUM NITRITE SOLUTION;INTRAVENOUS 300MG/10ML (30MG/ML) Yes Yes
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 N203922-001 SODIUM NITRITE SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203922-001 9687506 2030-02-10 U-3394 Drug product 2022-06-28 N203922-001 9687506 2030-02-10 U-3395 Drug product 2022-06-28 N203922-001 8568793 2031-12-24 Drug substance, Drug product 2013-11-01
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 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203922-001 SODIUM NITRITE 300MG/10ML (30MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2012-02-14 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 3 · 100 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 N203922-001 9687506 2030-02-10 U-3394 Drug product 2022-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203922-001 9687506 2030-02-10 U-3395 Drug product 2022-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203922-001 8568793 2031-12-24 Drug substance, Drug product 2013-11-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203922-001 9687506 2030-02-10 U-3394 Drug product 2022-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203922-001 9687506 2030-02-10 U-3395 Drug product 2022-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203922-001 8568793 2031-12-24 Drug substance, Drug product 2013-11-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203922-001 9687506 2030-02-10 U-3394 Drug product 2022-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203922-001 9687506 2030-02-10 U-3395 Drug product 2022-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203922-001 8568793 2031-12-24 Drug substance, Drug product 2013-11-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203922-001 9687506 2030-02-10 U-3394 Drug product 2022-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203922-001 9687506 2030-02-10 U-3395 Drug product 2022-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203922-001 8568793 2031-12-24 Drug substance, Drug product 2013-11-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203922-001 9687506 2030-02-10 U-3394 Drug product 2022-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203922-001 9687506 2030-02-10 U-3395 Drug product 2022-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203922-001 8568793 2031-12-24 Drug substance, Drug product 2013-11-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203922-001 9687506 2030-02-10 U-3394 Drug product 2022-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203922-001 9687506 2030-02-10 U-3395 Drug product 2022-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203922-001 8568793 2031-12-24 Drug substance, Drug product 2013-11-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203922-001 9687506 2030-02-10 U-3394 Drug product 2022-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203922-001 9687506 2030-02-10 U-3395 Drug product 2022-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203922-001 8568793 2031-12-24 Drug substance, Drug product 2013-11-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203922-001 9687506 2030-02-10 U-3394 Drug product 2022-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203922-001 9687506 2030-02-10 U-3395 Drug product 2022-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203922-001 8568793 2031-12-24 Drug substance, Drug product 2013-11-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203922-001 9687506 2030-02-10 U-3394 Drug product 2022-06-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203922-001 9687506 2030-02-10 U-3395 Drug product 2022-06-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203922-001 8568793 2031-12-24 Drug substance, Drug product 2013-11-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203922-001 9687506 2030-02-10 U-3394 Drug product 2022-06-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203922-001 9687506 2030-02-10 U-3395 Drug product 2022-06-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203922-001 8568793 2031-12-24 Drug substance, Drug product 2013-11-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203922-001 9687506 2030-02-10 U-3394 Drug product 2022-06-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203922-001 9687506 2030-02-10 U-3395 Drug product 2022-06-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203922-001 8568793 2031-12-24 Drug substance, Drug product 2013-11-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203922-001 9687506 2030-02-10 U-3394 Drug product 2022-06-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203922-001 9687506 2030-02-10 U-3395 Drug product 2022-06-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203922-001 8568793 2031-12-24 Drug substance, Drug product 2013-11-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203922-001 9687506 2030-02-10 U-3394 Drug product 2022-06-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203922-001 9687506 2030-02-10 U-3395 Drug product 2022-06-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203922-001 8568793 2031-12-24 Drug substance, Drug product 2013-11-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203922-001 9687506 2030-02-10 U-3394 Drug product 2022-06-28 1e350fbaab3a…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 60267-311 Sodium Nitrite Sodium Nitrite Hope Pharmaceuticals NDA Current 60267-311 Sodium Nitrite Sodium Nitrite Hope Pharmaceuticals NDA Current 60267-311 Sodium Nitrite Sodium Nitrite Hope Pharmaceuticals NDA Current 60267-311 Sodium Nitrite Sodium Nitrite Hope Pharmaceuticals NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 65907 SUPPL 2021-01-14 65905 SUPPL 2021-01-14 50160 SUPPL 2017-10-24 50133 SUPPL 2017-10-23 44890 ORIG 2012-03-15 43447 ORIG 2012-03-15 32478 ORIG 2012-02-21 19502 ORIG 2012-02-17