FDA.reportPublic FDA data

Application 219684

Type
ANDA
Sponsor
BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDESOLUTION;INTRAMUSCULAR, INTRAVENOUSEQ 100MG BASE/10ML (EQ 10MG BASE/ML)NoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219684-001KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDEEQ 100MG BASE/10ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS2025-09-17
A219684-002KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDEEQ 50MG BASE/5ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRS2026-08-11

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
2026-09-14 22:38:342026-08A219684-001KETAMINE HYDROCHLORIDEEQ 100MG BASE/10ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS2025-09-1784e616aacf4f…
2026-09-14 22:38:342026-08A219684-002KETAMINE HYDROCHLORIDEEQ 50MG BASE/5ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRS2026-08-1184e616aacf4f…
2026-08-18 06:07:402026-07A219684-001KETAMINE HYDROCHLORIDEEQ 100MG BASE/10ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS2025-09-17caaa826d4ba7…
2026-08-18 06:07:402026-07A219684-002KETAMINE HYDROCHLORIDEEQ 50MG BASE/5ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRS2026-08-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219684-001KETAMINE HYDROCHLORIDEEQ 100MG BASE/10ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRS2025-09-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219684-001KETAMINE HYDROCHLORIDEEQ 100MG BASE/10ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRS2025-09-1731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219684-001KETAMINE HYDROCHLORIDEEQ 100MG BASE/10ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS2025-09-17a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDEBaxter Healthcare Corporation549d6ed3-3c9b-4ea2-8aaf-f61d43e046022025-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219684
application number: ANDA219684