Application 075885

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINERMILRINONE LACTATEINJECTABLE;INJECTIONEQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)NoNo
002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINERMILRINONE LACTATEINJECTABLE;INJECTIONEQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINERMILRINONE LACTATEEQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-28
A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINERMILRINONE LACTATEEQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / 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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTION2002-05-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2002-05-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2002-05-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2002-05-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2002-05-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2002-05-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2002-05-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2002-05-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2002-05-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2002-05-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2002-05-28bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075885-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075885-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075885-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075885-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075885-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075885-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075885-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075885-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075885-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075885-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075885-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075885-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075885-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075885-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A075885-001AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A075885-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075885-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A075885-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075885-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A075885-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075885-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A075885-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A075885-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075885-002AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075885-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075885-002AP1ea99ee380514…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075885-001AP19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075885-002AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075885-001AP1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075885-002AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075885-001AP13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075885-002AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075885-001AP1053a50430f4f…
2023-05-13 08:27 UTC2023-05A075885-002AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075885-001AP13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A075885-002AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075885-001AP13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075885-002AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075885-001AP1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A075885-002AP1f41ea6bd6efb…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Milrinone LactateMILRINONE LACTATEMullan Pharmaceutical Inc.07dddead-22ed-004c-e063-6294a90a76fc2026-07-27Warnings, Adverse reactionsName fallback
generic name: MILRINONE LACTATE
Milrinone LactateMILRINONE LACTATEShandong New Time Pharmaceutical Co., Ltd.0fdaee3c-2144-4ca7-9868-54d251f468c02026-06-13Warnings, Adverse reactionsName fallback
generic name: MILRINONE LACTATE
MILRINONE LACTATEMILRINONE LACTATEHospira, Inc.813e8ca2-de54-4a7c-a2d2-8bd44396c3412025-09-26Warnings, Adverse reactionsName fallback
generic name: MILRINONE LACTATE
Milrinone LactateMILRINONE LACTATEHikma Pharmaceuticals USA Inc.88f78780-399f-4780-be19-205739db16822025-05-08Warnings, Adverse reactionsName fallback
generic name: MILRINONE LACTATE
Milrinone LactateMILRINONE LACTATECaplin Steriles Limitedcbe097f8-9599-4f5b-bdf3-3f43d3e3461b2025-02-14Warnings, Adverse reactionsName fallback
generic name: MILRINONE LACTATE
Milrinone LactateMILRINONE LACTATEHikma Pharmaceuticals USA Inc.b3c936b3-5c86-4d87-9544-e94e95d0245f2023-11-20Warnings, Adverse reactionsName fallback
generic name: MILRINONE LACTATE
Milrinone LactateMILRINONE LACTATEArmas Pharmaceuticals Inc.fde1e354-4f15-4ade-9ae3-db2ba67e04312023-04-05Warnings, Adverse reactionsName fallback
generic name: MILRINONE LACTATE
Milrinone LactateMILRINONE LACTATEFresenius Kabi USA, LLCac43ba6b-635d-4129-8eea-96f3f5a4785e2023-03-17Warnings, Adverse reactionsName fallback
generic name: MILRINONE LACTATE
Milrinone LactateMILRINONE LACTATESomerset Therapeutics, LLCce43e850-4e80-4c5b-8811-9cb65824768c2022-09-23Warnings, Adverse reactionsName fallback
generic name: MILRINONE LACTATE
Milrinone LactateMILRINONE LACTATEMeitheal Pharmaceuticals Inc.6c6b69f9-e229-4a93-a108-9eafdab614f02022-01-13Warnings, Adverse reactionsName fallback
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
generic name: MILRINONE LACTATE
Milrinone Lactate in DextroseMILRINONE LACTATEBaxter Healthcare Corporation8fd0f93a-6150-4020-b7ee-4b95b520f6ce2018-05-30Warnings, Adverse reactionsName fallback
generic name: MILRINONE LACTATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-2776Milrinone LactateMilrinone LactateHospira, Inc.ANDACurrent
0409-2776Milrinone LactateMilrinone LactateHospira, Inc.ANDACurrent
0409-2776Milrinone LactateMilrinone LactateHospira, Inc.ANDACurrent
0409-2776Milrinone LactateMilrinone LactateHospira, Inc.ANDACurrent
0409-2776Milrinone LactateMilrinone LactateHospira, Inc.ANDACurrent