FDA.reportPublic FDA data

Application 075830

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MILRINONE LACTATEMILRINONE LACTATEINJECTABLE;INJECTIONEQ 1MG BASE/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
A075830-001MILRINONE LACTATEMILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTION2002-05-28

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 22:54:322026-06A075830-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTION2002-05-28a50c72e98297…

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Milrinone LactateMILRINONE LACTATEShandong New Time Pharmaceutical Co., Ltd.0fdaee3c-2144-4ca7-9868-54d251f468c02026-06-13Warnings, Adverse reactionsName fallback
brand name: Milrinone Lactate
generic name: MILRINONE LACTATE
MILRINONE LACTATEMILRINONE LACTATEHospira, Inc.813e8ca2-de54-4a7c-a2d2-8bd44396c3412025-09-26Warnings, Adverse reactionsName fallback
brand name: MILRINONE LACTATE
generic name: MILRINONE LACTATE
Milrinone LactateMILRINONE LACTATEHikma Pharmaceuticals USA Inc.88f78780-399f-4780-be19-205739db16822025-05-08Warnings, Adverse reactionsName fallback
brand name: Milrinone Lactate
generic name: MILRINONE LACTATE
Milrinone LactateMILRINONE LACTATECaplin Steriles Limitedcbe097f8-9599-4f5b-bdf3-3f43d3e3461b2025-02-14Warnings, Adverse reactionsName fallback
brand name: Milrinone Lactate
generic name: MILRINONE LACTATE
Milrinone LactateMILRINONE LACTATEMullan Pharmaceutical Inc.07dddead-22ed-004c-e063-6294a90a76fc2025-01-15Warnings, Adverse reactionsName fallback
brand name: Milrinone Lactate
generic name: MILRINONE LACTATE
Milrinone LactateMILRINONE LACTATEHikma Pharmaceuticals USA Inc.b3c936b3-5c86-4d87-9544-e94e95d0245f2023-11-20Warnings, Adverse reactionsName fallback
brand name: Milrinone Lactate
generic name: MILRINONE LACTATE
Milrinone LactateMILRINONE LACTATEArmas Pharmaceuticals Inc.fde1e354-4f15-4ade-9ae3-db2ba67e04312023-04-05Warnings, Adverse reactionsName fallback
brand name: Milrinone Lactate
generic name: MILRINONE LACTATE
Milrinone LactateMILRINONE LACTATEFresenius Kabi USA, LLCac43ba6b-635d-4129-8eea-96f3f5a4785e2023-03-17Warnings, Adverse reactionsName fallback
brand name: Milrinone Lactate
generic name: MILRINONE LACTATE
Milrinone LactateMILRINONE LACTATE IN 5% DEXTROSEEugia US LLC4e489fab-75bc-4514-9bf2-85b8ed08a1b02023-02-01Warnings, Adverse reactionsName fallback
brand name: Milrinone Lactate
Milrinone LactateMILRINONE LACTATESomerset Therapeutics, LLCce43e850-4e80-4c5b-8811-9cb65824768c2022-09-23Warnings, Adverse reactionsName fallback
brand name: Milrinone Lactate
generic name: MILRINONE LACTATE
Milrinone LactateMILRINONE LACTATEMeitheal Pharmaceuticals Inc.6c6b69f9-e229-4a93-a108-9eafdab614f02022-01-13Warnings, Adverse reactionsName fallback
brand name: Milrinone Lactate
generic name: MILRINONE LACTATE
Milrinone Lactate in DextroseMILRINONE LACTATEGland Pharma Limited838da14b-c070-4c09-b088-99e7c64d99642021-08-25Warnings, Adverse reactionsName fallback
generic name: MILRINONE LACTATE
Milrinone Lactate in DextroseMILRINONE LACTATESagent Pharmaceuticalsbb0157d0-a414-43fa-81e0-8c92d717f1b22020-11-20Warnings, Adverse reactionsName fallback
generic name: MILRINONE LACTATE
Milrinone LactateMILRINONE LACTATEHikma Pharmaceuticals USA Inc.bb7500f8-dbfd-4c8a-ac2e-5533609c39702018-06-01Warnings, Adverse reactionsName fallback
brand name: Milrinone Lactate
generic name: MILRINONE LACTATE
Milrinone Lactate in DextroseMILRINONE LACTATEBaxter Healthcare Corporation8fd0f93a-6150-4020-b7ee-4b95b520f6ce2018-05-30Warnings, Adverse reactionsName fallback
generic name: MILRINONE LACTATE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31033ORIG2003-12-24
22509ORIG2003-12-24
18426ORIG2003-12-24
31032ORIG2003-04-15