Application 207092

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	POWDER;INTRAVENOUS	50MG/VIAL	No	No
002	CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	POWDER;INTRAVENOUS	70MG/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207092-001	CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP	RS	2017-09-29
A207092-002	CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP	RS	2017-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207092-001	AP
A207092-002	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP	RS	2017-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP	RS	2017-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207092-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207092-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	AP		2017-09-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207092-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207092-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207092-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207092-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207092-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207092-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207092-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207092-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207092-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207092-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207092-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207092-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207092-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207092-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207092-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207092-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207092-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207092-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207092-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207092-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207092-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207092-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207092-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207092-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207092-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207092-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207092-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207092-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207092-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207092-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207092-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207092-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207092-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207092-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207092-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207092-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207092-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207092-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207092-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207092-002	AP	1	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Caspofungin Acetate	CASPOFUNGIN ACETATE	Sagent Pharmaceuticals	08fb61ee-a05a-4ce1-934c-8cd26c5733db	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207092 application number: ANDA207092
Caspofungin Acetate	CASPOFUNGIN ACETATE	Fosun Pharma USA Inc.	cbd33696-e059-4e27-a782-95e23e8159b8	2022-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207092 application number: ANDA207092 ndc (product): 72266-106 ndc (product): 72266-107
Caspofungin Acetate	CASPOFUNGIN ACETATE	Gland Pharma Limited	29da357e-e7fc-46af-bf20-806a1e4b5391	2022-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207092 application number: ANDA207092 ndc (product): 68083-159 ndc (product): 68083-158

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-613	Caspofungin Acetate	caspofungin acetate	Alvogen Inc.	ANDA	Current
47781-613	Caspofungin Acetate	caspofungin acetate	Alvogen Inc.	ANDA	Current
47781-613	Caspofungin Acetate	caspofungin acetate	Alvogen Inc.	ANDA	Current
47781-614	Caspofungin Acetate	caspofungin acetate	Alvogen Inc.	ANDA	Current
47781-614	Caspofungin Acetate	caspofungin acetate	Alvogen Inc.	ANDA	Current
47781-614	Caspofungin Acetate	caspofungin acetate	Alvogen Inc.	ANDA	Current
68083-158	Caspofungin Acetate	Caspofungin Acetate	Gland Pharma Limited	ANDA	Current
68083-158	Caspofungin Acetate	Caspofungin Acetate	Gland Pharma Limited	ANDA	Current
68083-158	Caspofungin Acetate	Caspofungin Acetate	Gland Pharma Limited	ANDA	Current
68083-159	Caspofungin Acetate	Caspofungin Acetate	Gland Pharma Limited	ANDA	Current
68083-159	Caspofungin Acetate	Caspofungin Acetate	Gland Pharma Limited	ANDA	Current
68083-159	Caspofungin Acetate	Caspofungin Acetate	Gland Pharma Limited	ANDA	Current
70860-106	Caspofungin Acetate	caspofungin acetate	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-106	Caspofungin Acetate	caspofungin acetate	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-106	Caspofungin Acetate	caspofungin acetate	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-107	Caspofungin Acetate	caspofungin acetate	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-107	Caspofungin Acetate	caspofungin acetate	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-107	Caspofungin Acetate	caspofungin acetate	Athenex Pharmaceutical Division, LLC.	ANDA	Current
72266-106	Caspofungin Acetate	Caspofungin Acetate	Fosun Pharma USA Inc.	ANDA	Current
72266-106	Caspofungin Acetate	Caspofungin Acetate	Fosun Pharma USA Inc.	ANDA	Current
72266-106	Caspofungin Acetate	Caspofungin Acetate	Fosun Pharma USA Inc.	ANDA	Current
72266-107	Caspofungin Acetate	Caspofungin Acetate	Fosun Pharma USA Inc.	ANDA	Current
72266-107	Caspofungin Acetate	Caspofungin Acetate	Fosun Pharma USA Inc.	ANDA	Current
72266-107	Caspofungin Acetate	Caspofungin Acetate	Fosun Pharma USA Inc.	ANDA	Current
72611-700	caspofungin acetate	caspofungin acetate	Almaject, Inc.	ANDA	Current
72611-700	caspofungin acetate	caspofungin acetate	Almaject, Inc.	ANDA	Current
72611-700	caspofungin acetate	caspofungin acetate	Almaject, Inc.	ANDA	Current
72611-702	Caspofungin Acetate	caspofungin acetate	Almaject, Inc.	ANDA	Current
72611-702	Caspofungin Acetate	caspofungin acetate	Almaject, Inc.	ANDA	Current
72611-702	Caspofungin Acetate	caspofungin acetate	Almaject, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49957	ORIG	2017-10-05