FDA.reportPublic FDA data

Application 216142

Type
NDA
Sponsor
BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MICAFUNGIN IN SODIUM CHLORIDE 0.9%MICAFUNGIN SODIUMSOLUTION;INTRAVENOUSEQ 50MG BASE/50ML (EQ 1MG BASE/ML)YesYes
002MICAFUNGIN IN SODIUM CHLORIDE 0.9%MICAFUNGIN SODIUMSOLUTION;INTRAVENOUSEQ 100MG BASE/100ML (EQ 1MG BASE/ML)YesYes
003MICAFUNGIN IN SODIUM CHLORIDE 0.9%MICAFUNGIN SODIUMSOLUTION;INTRAVENOUSEQ 150MG BASE/150ML (EQ 1MG BASE/ML)YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N216142-001MICAFUNGIN IN SODIUM CHLORIDE 0.9%MICAFUNGIN SODIUMEQ 50MG BASE/50ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29
N216142-002MICAFUNGIN IN SODIUM CHLORIDE 0.9%MICAFUNGIN SODIUMEQ 100MG BASE/100ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29
N216142-003MICAFUNGIN IN SODIUM CHLORIDE 0.9%MICAFUNGIN SODIUMEQ 150MG BASE/150ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N216142-001124031732037-12-15Drug product2025-09-12
N216142-002124031732037-12-15Drug product2025-09-12
N216142-003124031732037-12-15Drug product2025-09-12

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 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N216142-001MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 50MG BASE/50ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216142-002MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 100MG BASE/100ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216142-003MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 150MG BASE/150ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216142-001MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 50MG BASE/50ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216142-002MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 100MG BASE/100ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216142-003MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 150MG BASE/150ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N216142-001MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 50MG BASE/50ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216142-002MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 100MG BASE/100ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216142-003MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 150MG BASE/150ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216142-001MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 50MG BASE/50ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216142-002MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 100MG BASE/100ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216142-003MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 150MG BASE/150ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216142-001MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 50MG BASE/50ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216142-002MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 100MG BASE/100ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216142-003MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 150MG BASE/150ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216142-001MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 50MG BASE/50ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216142-002MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 100MG BASE/100ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216142-003MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 150MG BASE/150ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216142-001MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 50MG BASE/50ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216142-002MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 100MG BASE/100ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216142-003MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 150MG BASE/150ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216142-001MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 50MG BASE/50ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216142-002MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 100MG BASE/100ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216142-003MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 150MG BASE/150ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216142-001MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 50MG BASE/50ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216142-002MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 100MG BASE/100ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216142-003MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 150MG BASE/150ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N216142-001MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 50MG BASE/50ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N216142-002MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 100MG BASE/100ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N216142-003MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 150MG BASE/150ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216142-001MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 50MG BASE/50ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216142-002MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 100MG BASE/100ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216142-003MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 150MG BASE/150ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216142-001MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 50MG BASE/50ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216142-002MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 100MG BASE/100ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216142-003MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 150MG BASE/150ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216142-001MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 50MG BASE/50ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216142-002MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 100MG BASE/100ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216142-003MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 150MG BASE/150ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N216142-001MICAFUNGIN IN SODIUM CHLORIDE 0.9%EQ 50MG BASE/50ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2023-09-298072bd15b7f6…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N216142-001124031732037-12-15Drug product2025-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216142-002124031732037-12-15Drug product2025-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216142-003124031732037-12-15Drug product2025-09-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216142-001124031732037-12-15Drug product2025-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216142-002124031732037-12-15Drug product2025-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216142-003124031732037-12-15Drug product2025-09-1231067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216142-001124031732037-12-15Drug product2025-09-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216142-002124031732037-12-15Drug product2025-09-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216142-003124031732037-12-15Drug product2025-09-12a50c72e98297…

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
Micafungin in Sodium ChlorideMICAFUNGIN IN SODIUM CHLORIDEBaxter Healthcare Corporationa95f901e-0ac4-4ec0-9720-9c6a066cd06c2023-09-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 216142
application number: NDA216142

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77427ORIG 2024-02-08
75663ORIG 2023-10-03
75661ORIG 2023-10-03