Application 215381

Type: ANDA
Sponsor: NANJING KING-FRIEND

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
A215381-001	MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-09-28
A215381-002	MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215381-001	AP
A215381-002	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.

Product history page 1 of 2 · 52 observed 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	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215381-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215381-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-09-28	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215381-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215381-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215381-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215381-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215381-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215381-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215381-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215381-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215381-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215381-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215381-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215381-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215381-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215381-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215381-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215381-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215381-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215381-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215381-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215381-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215381-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215381-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215381-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215381-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215381-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215381-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215381-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215381-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215381-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215381-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215381-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215381-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215381-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215381-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215381-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215381-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215381-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215381-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215381-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215381-002	AP	1	`a67488948f0b…`

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 SODIUM	Meitheal Pharmaceuticals Inc.	579ff093-0359-4e0e-a6ea-2b6adac80bf0	2024-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215381 application number: ANDA215381 ndc (product): 71288-028 ndc (product): 71288-029

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71288-028	Micafungin	Micafungin sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-029	Micafungin	Micafungin sodium	Meitheal Pharmaceuticals Inc.	ANDA	Current