FDA.reportPublic FDA data

Application 075392

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPOFOLPROPOFOLINJECTABLE;INJECTION10MG/MLNoNo

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
A075392-001PROPOFOLPROPOFOL10MG/MLINJECTABLE / INJECTION2000-09-19

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 UTC2022-10A075392-001PROPOFOL10MG/MLINJECTABLE / INJECTION2000-09-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075392-001PROPOFOL10MG/MLINJECTABLE / INJECTION2000-09-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075392-001PROPOFOL10MG/MLINJECTABLE / INJECTION2000-09-19cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075392-001PROPOFOL10MG/MLINJECTABLE / INJECTION2000-09-19a50c72e98297…

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PropofolPROPOFOLCivica, Inc9ba70032-40c2-41c5-9f99-d1f94032d3dc2026-09-18Warnings, Adverse reactionsName fallback
brand name: Propofol
generic name: PROPOFOL
PROPOFOLPROPOFOLHospira, Inc.28d7ba00-f824-4e55-139a-03f509c099db2026-08-13Warnings, Adverse reactionsName fallback
brand name: PROPOFOL
generic name: PROPOFOL
propofolPROPOFOLMeitheal Pharmaceuticals Inc.548d5192-2e5e-4c1b-8f17-940b6e791ae52025-12-12Warnings, Adverse reactionsName fallback
brand name: propofol
generic name: PROPOFOL
DiprivanPROPOFOLFresenius Kabi USA, LLCe3105799-a4b6-f3f4-e6e2-b2b29bbdb5382025-09-11Warnings, Adverse reactionsName fallback
generic name: PROPOFOL
DiprivanPROPOFOLFresenius Kabi USA, LLCfee3bd4a-ade3-41fa-839a-48e9af69bcf42025-09-10Warnings, Adverse reactionsName fallback
generic name: PROPOFOL
propofolPROPOFOLSagent Pharmaceuticalsfa93f173-7858-4d88-860e-76ab97e65c2f2025-06-07Warnings, Adverse reactionsName fallback
brand name: propofol
generic name: PROPOFOL
PROPOFOLPROPOFOLAmneal Pharmaceuticals Private Limited6833edd6-ba8a-4b97-a872-ab253c64a9032025-05-20Warnings, Adverse reactionsName fallback
brand name: PROPOFOL
generic name: PROPOFOL
PropofolPROPOFOLAvenacy, LLCde351d5f-581d-4768-a4af-fbd8e5bce2642025-04-30Warnings, Adverse reactionsName fallback
brand name: Propofol
generic name: PROPOFOL
DiprivanPROPOFOLFresenius Kabi USA, LLCd1ae9e26-ffd6-43df-bbd6-869cdede6afe2025-04-21Warnings, Adverse reactionsName fallback
generic name: PROPOFOL
DiprivanPROPOFOLFresenius Kabi USA, LLCee0c3437-614d-4631-a061-257f5f60c70b2025-02-20Warnings, Adverse reactionsName fallback
generic name: PROPOFOL
PROPOFOLPROPOFOLHF Acquisition Co LLC, DBA HealthFirst99af9e0a-c268-84ca-e053-2a95a90a0a3e2025-01-08Warnings, Adverse reactionsName fallback
brand name: PROPOFOL
generic name: PROPOFOL
PROPOFOLPROPOFOLHF Acquisition Co LLC, DBA HealthFirst99c8438a-2b3c-796e-e053-2a95a90a02002025-01-08Warnings, Adverse reactionsName fallback
brand name: PROPOFOL
generic name: PROPOFOL
DiprivanPROPOFOLFresenius Kabi USA, LLC5cec3b97-5183-4a9d-accd-21e76c99d3dd2024-04-18Warnings, Adverse reactionsName fallback
generic name: PROPOFOL
PROPOFOLPROPOFOLHF Acquisition Co LLC, DBA HealthFirst7b9599e0-5bad-742d-e053-2991aa0aee972022-12-09Warnings, Adverse reactionsName fallback
brand name: PROPOFOL
generic name: PROPOFOL
PROPOFOLPROPOFOLHikma Pharmaceuticals USA Inc.fdb77e13-f5a7-4c4a-9f8e-338b702239c82022-11-18Warnings, Adverse reactionsName fallback
brand name: PROPOFOL
generic name: PROPOFOL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44255ORIG2007-06-18
39483ORIG2004-06-14
42989ORIG2003-08-04
8644ORIG2000-09-19