FDA.reportPublic FDA data

Application 203922

Type
NDA
Sponsor
HOPE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM NITRITESODIUM NITRITESOLUTION;INTRAVENOUS300MG/10ML (30MG/ML)YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N203922-001SODIUM NITRITESODIUM NITRITE300MG/10ML (30MG/ML)SOLUTION / INTRAVENOUSRLD, RS2012-02-14

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N203922-00196875062030-02-10U-3394Drug product2022-06-28
N203922-00196875062030-02-10U-3395Drug product2022-06-28
N203922-00185687932031-12-24Drug substance, Drug product2013-11-01

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N203922-001SODIUM NITRITE300MG/10ML (30MG/ML)SOLUTION / INTRAVENOUSRLD, RS2012-02-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N203922-001SODIUM NITRITE300MG/10ML (30MG/ML)SOLUTION / INTRAVENOUSRLD, RS2012-02-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N203922-001SODIUM NITRITE300MG/10ML (30MG/ML)SOLUTION / INTRAVENOUSRLD, RS2012-02-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N203922-001SODIUM NITRITE300MG/10ML (30MG/ML)SOLUTION / INTRAVENOUSRLD, RS2012-02-14a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 106 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N203922-00196875062030-02-10U-3394Drug product2022-06-28c2088c7a36db…
2026-10-15 13:18:302026-09N203922-00196875062030-02-10U-3395Drug product2022-06-28c2088c7a36db…
2026-10-15 13:18:302026-09N203922-00185687932031-12-24Drug substance, Drug product2013-11-01c2088c7a36db…
2026-09-14 22:38:342026-08N203922-00196875062030-02-10U-3394Drug product2022-06-2884e616aacf4f…
2026-09-14 22:38:342026-08N203922-00196875062030-02-10U-3395Drug product2022-06-2884e616aacf4f…
2026-09-14 22:38:342026-08N203922-00185687932031-12-24Drug substance, Drug product2013-11-0184e616aacf4f…
2026-08-18 06:07:402026-07N203922-00196875062030-02-10U-3394Drug product2022-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07N203922-00196875062030-02-10U-3395Drug product2022-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07N203922-00185687932031-12-24Drug substance, Drug product2013-11-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N203922-00196875062030-02-10U-3394Drug product2022-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203922-00196875062030-02-10U-3395Drug product2022-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203922-00185687932031-12-24Drug substance, Drug product2013-11-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203922-00196875062030-02-10U-3394Drug product2022-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203922-00196875062030-02-10U-3395Drug product2022-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203922-00185687932031-12-24Drug substance, Drug product2013-11-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N203922-00196875062030-02-10U-3394Drug product2022-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203922-00196875062030-02-10U-3395Drug product2022-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203922-00185687932031-12-24Drug substance, Drug product2013-11-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203922-00196875062030-02-10U-3394Drug product2022-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203922-00196875062030-02-10U-3395Drug product2022-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203922-00185687932031-12-24Drug substance, Drug product2013-11-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203922-00196875062030-02-10U-3394Drug product2022-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203922-00196875062030-02-10U-3395Drug product2022-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203922-00185687932031-12-24Drug substance, Drug product2013-11-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203922-00196875062030-02-10U-3394Drug product2022-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203922-00196875062030-02-10U-3395Drug product2022-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203922-00185687932031-12-24Drug substance, Drug product2013-11-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203922-00196875062030-02-10U-3394Drug product2022-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203922-00196875062030-02-10U-3395Drug product2022-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203922-00185687932031-12-24Drug substance, Drug product2013-11-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203922-00196875062030-02-10U-3394Drug product2022-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203922-00196875062030-02-10U-3395Drug product2022-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203922-00185687932031-12-24Drug substance, Drug product2013-11-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203922-00196875062030-02-10U-3394Drug product2022-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203922-00196875062030-02-10U-3395Drug product2022-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203922-00185687932031-12-24Drug substance, Drug product2013-11-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N203922-00196875062030-02-10U-3394Drug product2022-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N203922-00196875062030-02-10U-3395Drug product2022-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N203922-00185687932031-12-24Drug substance, Drug product2013-11-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203922-00196875062030-02-10U-3394Drug product2022-06-2879d66fd596c7…

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60267-311Sodium NitriteSodium NitriteHope PharmaceuticalsNDACurrent
60267-311Sodium NitriteSodium NitriteHope PharmaceuticalsNDACurrent
60267-311Sodium NitriteSodium NitriteHope PharmaceuticalsNDACurrent
60267-311Sodium NitriteSodium NitriteHope PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65907SUPPL2021-01-14
65905SUPPL2021-01-14
50160SUPPL2017-10-24
50133SUPPL2017-10-23
44890ORIG2012-03-15
43447ORIG2012-03-15
32478ORIG2012-02-21
19502ORIG2012-02-17