Application 212125

Type: NDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	INJECTABLE;INTRAVENOUS	EQ 50MG BASE/VIAL	No	No
002	MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	INJECTABLE;INTRAVENOUS	EQ 100MG BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N212125-001	MICAFUNGIN	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		RLD	2021-07-30
N212125-002	MICAFUNGIN	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS		RLD	2021-07-30

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 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212125-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212125-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-07-30	`bb7c543d1eb4…`

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 · 6 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
Mycamine	MICAFUNGIN SODIUM	Astellas Pharma US, Inc.	a064c4a7-25ec-4a2c-afc2-703491a4a38b	2020-07-23	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
71049	ORIG	2022-05-12
68254	ORIG	2021-08-02
65438	ORIG	2020-12-01