FDA.reportPublic FDA data

Application 012285

Type
NDA
Sponsor
RTRX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYNTOCINONOXYTOCINSOLUTION;NASAL40USP UNITS/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
N012285-001SYNTOCINONOXYTOCIN40USP UNITS/MLSOLUTION / NASALApproved before 1982

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 22:54:322026-06N012285-001SYNTOCINON40USP UNITS/MLSOLUTION / NASALApproved before 1982a50c72e98297…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PitocinOXYTOCINPar Health USA, LLC6d4b2c25-2e5d-49b5-93bc-2ae8a20916d12026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OXYTOCIN
PitocinOXYTOCINPar Health USA, LLC969d5b35-0add-4c23-9605-6a5b6ab65c952026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OXYTOCIN
PitocinOXYTOCINPar Health USA, LLC6e5a66fc-e507-497c-b5ce-44a8c95898ad2026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OXYTOCIN
OxytocinOXYTOCINFresenius Kabi USA, LLCc7fd585a-99b7-4309-b003-a6cbef05372c2026-01-12Warnings, Adverse reactionsName fallback
generic name: OXYTOCIN
OxytocinOXYTOCINREMEDYREPACK INC.b6f20a2c-3609-4b09-b8f7-8d8eaeb5c2422025-09-30Warnings, Adverse reactionsName fallback
generic name: OXYTOCIN
OxytocinOXYTOCINCardinal Health 107, LLC18fe8365-86e3-414e-84dc-c98e097a2f362025-06-20Warnings, Adverse reactionsName fallback
generic name: OXYTOCIN
OxytocinOXYTOCINFresenius Kabi USA, LLC4c4c4b69-8bf7-472c-aafe-29805ba5c9652025-03-24Warnings, Adverse reactionsName fallback
generic name: OXYTOCIN
OxytocinOXYTOCINFresenius Kabi USA, LLC6d7d1280-f286-4f39-89f3-2b96571810e62024-10-15Warnings, Adverse reactionsName fallback
generic name: OXYTOCIN
PitocinOXYTOCINPar Health USA, LLCdddcdcc3-cd4d-4573-98ac-9468bea23a8b2024-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OXYTOCIN
OxytocinOXYTOCINWest-Ward Pharmaceuticals Corpd16a48c5-6b71-40a0-bcda-204f043fe8322018-12-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OXYTOCIN