FDA.reportPublic FDA data

Application 205307

Type
ANDA
Sponsor
WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPOFOLPROPOFOLINJECTABLE;INJECTION10MG/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
A205307-001PROPOFOLPROPOFOL10MG/MLINJECTABLE / INJECTION2015-12-22

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 22:54:322026-06A205307-001PROPOFOL10MG/MLINJECTABLE / INJECTION2015-12-22a50c72e98297…

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 · 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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9943PROPOFOLpropofolHenry Schein, Inc.ANDACurrent
0591-2136PropofolPropofolActavis Pharma, Inc.ANDACurrent
0591-2136PropofolPropofolActavis Pharma, Inc.ANDACurrent
0591-2136PropofolPropofolActavis Pharma, Inc.ANDACurrent
0591-2136PropofolPropofolActavis Pharma, Inc.ANDACurrent
0591-2136PropofolPropofolActavis Pharma, Inc.ANDACurrent
50090-4569PropofolPropofolA-S Medication SolutionsANDACurrent
50090-4569PropofolPropofolA-S Medication SolutionsANDACurrent
52584-054PropofolPropofolGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-098PROPOFOLpropofolGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-098PROPOFOLpropofolGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-098PROPOFOLpropofolGeneral Injectables & Vaccines, Inc.ANDACurrent