Application 219712

Type: ANDA
Sponsor: HISUN PHARM HANGZHOU

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 1.

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
A219712-001	MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2026-01-21
A219712-002	MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2026-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A219712-001	AP
A219712-002	AP

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A219712-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2026-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219712-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2026-01-21	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219712-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2026-01-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219712-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2026-01-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A219712-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219712-002	AP	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219712-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219712-002	AP	1	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Micafungin	MICAFUNGIN	Hisun Pharmaceuticals USA, Inc.	230fcff4-ad4b-ea25-e063-6394a90a1fab	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219712 application number: ANDA219712