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 1.

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2021-12-28 21:50 UTC2021-12A075885-001MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2002-05-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A075885-002MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)INJECTABLE / INJECTIONAP2002-05-28782e0a99824c…

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#

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 · 14 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
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 LACTATEMullan Pharmaceutical Inc.07dddead-22ed-004c-e063-6294a90a76fc2025-01-15Warnings, 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