Application 203280

Type
ANDA
Sponsor
HOSPIRA INC

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
A203280-001MILRINONE LACTATEMILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A203280-001AP

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-033f01610625f2…
2019-09-15 20:21 UTC2019-09A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203280-001MILRINONE LACTATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2014-09-03cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203280-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203280-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203280-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203280-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203280-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203280-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203280-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203280-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203280-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203280-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203280-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203280-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203280-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203280-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203280-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203280-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203280-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203280-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203280-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203280-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203280-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A203280-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203280-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203280-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203280-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A203280-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203280-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203280-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203280-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203280-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203280-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203280-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203280-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203280-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203280-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203280-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203280-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203280-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203280-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203280-001AP1cb3db0bc1861…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILRINONE LACTATEMILRINONE LACTATEHospira, Inc.813e8ca2-de54-4a7c-a2d2-8bd44396c3412025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203280
application number: ANDA203280
ndc (product): 0409-0212

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-0212MILRINONE LACTATEMILRINONE LACTATEHospira, Inc.ANDACurrent
0409-0212MILRINONE LACTATEMILRINONE LACTATEHospira, Inc.ANDACurrent
0409-0212MILRINONE LACTATEMILRINONE LACTATEHospira, Inc.ANDACurrent