Application 216142

Type: NDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	MICAFUNGIN SODIUM	SOLUTION;INTRAVENOUS	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	Yes	Yes
002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	MICAFUNGIN SODIUM	SOLUTION;INTRAVENOUS	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	Yes	Yes
003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	MICAFUNGIN SODIUM	SOLUTION;INTRAVENOUS	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	MICAFUNGIN SODIUM	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29
N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	MICAFUNGIN SODIUM	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29
N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	MICAFUNGIN SODIUM	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N216142-001	12403173	2037-12-15	Drug product	2025-09-12
N216142-002	12403173	2037-12-15	Drug product	2025-09-12
N216142-003	12403173	2037-12-15	Drug product	2025-09-12

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 · 69 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`79d66fd596c7…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N216142-001	12403173	2037-12-15	Drug product	2025-09-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216142-002	12403173	2037-12-15	Drug product	2025-09-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216142-003	12403173	2037-12-15	Drug product	2025-09-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216142-001	12403173	2037-12-15	Drug product	2025-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216142-002	12403173	2037-12-15	Drug product	2025-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216142-003	12403173	2037-12-15	Drug product	2025-09-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216142-001	12403173	2037-12-15	Drug product	2025-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216142-002	12403173	2037-12-15	Drug product	2025-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216142-003	12403173	2037-12-15	Drug product	2025-09-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216142-001	12403173	2037-12-15	Drug product	2025-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216142-002	12403173	2037-12-15	Drug product	2025-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216142-003	12403173	2037-12-15	Drug product	2025-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216142-001	12403173	2037-12-15	Drug product	2025-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216142-002	12403173	2037-12-15	Drug product	2025-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216142-003	12403173	2037-12-15	Drug product	2025-09-12	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216142-001	12403173	2037-12-15	Drug product	2025-09-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216142-002	12403173	2037-12-15	Drug product	2025-09-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216142-003	12403173	2037-12-15	Drug product	2025-09-12	`a50c72e98297…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Micafungin	MICAFUNGIN SODIUM	Sagent Pharmaceuticals	33e579c1-b315-44cb-a690-e2dd2cdf44ee	2025-11-08	Warnings, Adverse reactions	Name fallback generic name: MICAFUNGIN SODIUM
Micafungin	MICAFUNGIN SODIUM	Fresenius Kabi USA, LLC	dc5241be-4b85-4f04-8553-9819603373b8	2025-10-23	Warnings, Adverse reactions	Name fallback generic name: MICAFUNGIN SODIUM
Micafungin	MICAFUNGIN SODIUM	Hikma Pharmaceuticals USA Inc.	8ba6f80c-05f0-4d75-930c-c8458db2e1c1	2025-08-22	Warnings, Adverse reactions	Name fallback generic name: MICAFUNGIN SODIUM
Micafungin	MICAFUNGIN SODIUM	Fresenius Kabi USA, LLC	f8198836-4011-40b9-af25-466ae08727f8	2024-10-09	Warnings, Adverse reactions	Name fallback generic name: MICAFUNGIN SODIUM
Micafungin	MICAFUNGIN SODIUM	Meitheal Pharmaceuticals Inc.	579ff093-0359-4e0e-a6ea-2b6adac80bf0	2024-08-13	Warnings, Adverse reactions	Name fallback generic name: MICAFUNGIN SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

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