FDA.reportPublic FDA data

Application 073465

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDEINJECTABLE;INJECTION25MG/MLNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A073465-001SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTION1992-03-30

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A073465-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTION1992-03-30a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium NitroprussideSODIUM NITROPRUSSIDESomerset Therapeutics, LLC2122b9c1-0af4-493b-82cc-63eee02f987f2026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sodium Nitroprusside
generic name: SODIUM NITROPRUSSIDE
Sodium nitroprussideSODIUM NITROPRUSSIDEMylan Institutional LLC6fbfb86c-da8d-4741-b1e0-7000e2bbad5f2026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sodium nitroprusside
generic name: SODIUM NITROPRUSSIDE
Sodium NitroprussideSODIUM NITROPRUSSIDEDr.Reddy's Laboratories Inc.,a3b83d0e-b8f7-5e90-c363-1edfcd27a33d2025-11-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sodium Nitroprusside
generic name: SODIUM NITROPRUSSIDE
Sodium NitroprussideSODIUM NITROPRUSSIDECaplin Steriles Limiteda8c5d04b-c6cb-46e6-b90c-e858a0a524062025-10-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sodium Nitroprusside
generic name: SODIUM NITROPRUSSIDE
SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDEMicro Labs Limited5a599880-c133-44ef-a9f2-bd1b681563be2025-02-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SODIUM NITROPRUSSIDE
generic name: SODIUM NITROPRUSSIDE
Sodium NitroprussideSODIUM NITROPRUSSIDEDr.Reddy's Laboratories Inc.,5a689f89-3cbd-f9fa-13cc-26063feb9c832024-12-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sodium Nitroprusside
generic name: SODIUM NITROPRUSSIDE
Sodium NitroprussideSODIUM NITROPRUSSIDEMeitheal Pharmaceuticals Inc.820eadcb-1230-4b17-a652-e69b52b3c12f2024-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sodium Nitroprusside
generic name: SODIUM NITROPRUSSIDE
sodium nitroprussideSODIUM NITROPRUSSIDEHainan Poly Pharm. Co., Ltd.1f875445-f8e4-b097-e063-6294a90ad5442024-08-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: sodium nitroprusside
generic name: SODIUM NITROPRUSSIDE
SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDEArmas Pharmaceuticals Inc.d3f1276a-5944-48e3-8ff1-19995ffb7ef92023-07-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SODIUM NITROPRUSSIDE
generic name: SODIUM NITROPRUSSIDE
Sodium NitroprussideSODIUM NITROPRUSSIDEHainan Poly Pharm. Co., Ltd.72a9b7df-3a2f-4c16-93a9-b645bc0e81432022-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sodium Nitroprusside
generic name: SODIUM NITROPRUSSIDE
Sodium NitroprussideSODIUM NITROPRUSSIDEBE Pharmaceuticals Inc.01841345-bed3-458f-8e99-911fbd2865122021-07-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sodium Nitroprusside
generic name: SODIUM NITROPRUSSIDE
SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDEAuroMedics Pharma LLC41e11afb-5fa4-4212-889d-1092dbd0702a2020-12-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SODIUM NITROPRUSSIDE
generic name: SODIUM NITROPRUSSIDE
sodium nitroprussideSODIUM NITROPRUSSIDESlate Run Pharmaceuticals, LLC01dfae56-3d9b-448a-84a7-03a54a533eb12020-10-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: sodium nitroprusside
generic name: SODIUM NITROPRUSSIDE
Sodium nitroprussideSODIUM NITROPRUSSIDEMylan Institutional LLCa8999285-16b1-473d-8e92-684f581534f62020-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sodium nitroprusside
generic name: SODIUM NITROPRUSSIDE
Sodium nitroprussideSODIUM NITROPRUSSIDEAmneal Pharmaceuticals LLC2fa687a2-10e7-45ae-953a-9d63564c29082019-11-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sodium nitroprusside
generic name: SODIUM NITROPRUSSIDE
NIPRIDE RTUSODIUM NITROPRUSSIDEEXELA PHARMA SCIENCES, LLC5acf0836-93ff-4064-b888-3f560e8a558d2018-07-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM NITROPRUSSIDE