FDA.reportPublic FDA data

Application 074816

Type
ANDA
Sponsor
GENSIA SICOR PHARMS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROPOFOLPROPOFOLAnthea Pharma Private Limitedf23fe3c5-aa37-4ecc-ad76-f13c1a1dabe22026-07-15Warnings, Adverse reactionsName fallback
brand name: PROPOFOL
generic name: PROPOFOL
PropofolPROPOFOLCivica, Inc9ba70032-40c2-41c5-9f99-d1f94032d3dc2026-05-14Warnings, Adverse reactionsName fallback
brand name: Propofol
generic name: PROPOFOL
PROPOFOLPROPOFOLHospira, Inc.28d7ba00-f824-4e55-139a-03f509c099db2025-12-17Warnings, 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
PropofolPROPOFOLPfizer Laboratories Div Pfizer Inc3acf8e6c-827d-11e2-9e96-0800200c9a662025-11-18Warnings, 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
propofolPROPOFOLNorthStar Rx LLC5ec25932-6c21-4cd5-8f60-80761f2e20a62025-05-26Warnings, Adverse reactionsName fallback
brand name: propofol
generic name: PROPOFOL
propofolPROPOFOLHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.10272dc1-657d-4798-a34a-b6341b92e5602025-05-26Warnings, 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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30704ORIG2004-06-14