Application 021227

Type: NDA
Sponsor: MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CANCIDAS	CASPOFUNGIN ACETATE	POWDER;INTRAVENOUS	50MG/VIAL	Yes	Yes
002	CANCIDAS	CASPOFUNGIN ACETATE	POWDER;INTRAVENOUS	70MG/VIAL	Yes	Yes

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

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
N021227-001	CANCIDAS	CASPOFUNGIN ACETATE	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2001-01-26
N021227-002	CANCIDAS	CASPOFUNGIN ACETATE	70MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2001-01-26

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 · 88 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
2026-10-15 13:18:30	2026-09	N021227-001	CANCIDAS	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2001-01-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021227-002	CANCIDAS	70MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2001-01-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021227-001	CANCIDAS	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2001-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021227-002	CANCIDAS	70MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2001-01-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021227-001	CANCIDAS	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2001-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021227-002	CANCIDAS	70MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2001-01-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS		RLD	2001-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021227-001	CANCIDAS	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021227-002	CANCIDAS	70MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2001-01-26	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021227-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021227-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021227-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021227-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021227-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021227-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021227-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021227-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021227-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021227-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021227-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021227-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021227-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021227-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021227-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021227-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021227-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021227-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021227-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021227-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021227-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021227-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021227-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021227-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021227-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021227-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021227-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021227-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021227-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021227-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021227-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021227-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021227-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021227-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021227-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021227-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021227-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021227-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021227-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021227-002	AP	1	`b00525d2431f…`

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
Caspofungin Acetate	CASPOFUNGIN ACETATE	Sagent Pharmaceuticals	08fb61ee-a05a-4ce1-934c-8cd26c5733db	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: CASPOFUNGIN ACETATE
Caspofungin Acetate	CASPOFUNGIN ACETATE	Fresenius Kabi USA, LLC	e76d8d83-3691-451c-a32c-d91448c54d16	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: CASPOFUNGIN ACETATE
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.	2b9bf716-9d4b-4264-985b-6fe98f5e729d	2025-10-08	Warnings, Adverse reactions	Name fallback generic name: CASPOFUNGIN ACETATE
Caspofungin Acetate	CASPOFUNGIN ACETATE	Fosun Pharma USA Inc.	cbd33696-e059-4e27-a782-95e23e8159b8	2022-03-21	Warnings, Adverse reactions	Name fallback generic name: CASPOFUNGIN ACETATE
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	Sandoz Inc	722facc6-d4ea-4975-b83e-3ae63df69ed2	2022-01-31	Warnings, Adverse reactions	Name fallback generic name: CASPOFUNGIN ACETATE
Caspofungin Acetate	CASPOFUNGIN ACETATE	Gland Pharma Limited	29da357e-e7fc-46af-bf20-806a1e4b5391	2022-01-19	Warnings, Adverse reactions	Name fallback generic name: CASPOFUNGIN ACETATE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-3822	CANCIDAS	CASPOFUNGIN ACETATE	Merck Sharp & Dohme Corp.	NDA	Current
0006-3822	CANCIDAS	CASPOFUNGIN ACETATE	Merck Sharp & Dohme Corp.	NDA	Current
0006-3822	CANCIDAS	CASPOFUNGIN ACETATE	Merck Sharp & Dohme Corp.	NDA	Current
0006-3822	CANCIDAS	CASPOFUNGIN ACETATE	Merck Sharp & Dohme Corp.	NDA	Current
0006-3822	CANCIDAS	CASPOFUNGIN ACETATE	Merck Sharp & Dohme LLC	NDA	Current
0006-3823	CANCIDAS	CASPOFUNGIN ACETATE	Merck Sharp & Dohme Corp.	NDA	Current
0006-3823	CANCIDAS	CASPOFUNGIN ACETATE	Merck Sharp & Dohme Corp.	NDA	Current
0006-3823	CANCIDAS	CASPOFUNGIN ACETATE	Merck Sharp & Dohme Corp.	NDA	Current
0006-3823	CANCIDAS	CASPOFUNGIN ACETATE	Merck Sharp & Dohme Corp.	NDA	Current
0006-3823	CANCIDAS	CASPOFUNGIN ACETATE	Merck Sharp & Dohme LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69538	SUPPL	2021-12-13
69111	SUPPL	2021-10-26
57713	SUPPL	2019-02-20
57500	SUPPL	2019-02-12
52988	SUPPL	2018-03-15
52978	SUPPL	2018-03-15
49624	SUPPL	2017-08-30
49560	SUPPL	2017-08-25
49403	SUPPL	2017-08-15
49340	SUPPL	2017-08-11
27136	SUPPL	2016-04-14
4700	SUPPL	2016-04-14
36414	SUPPL	2016-04-13
14679	SUPPL	2016-04-13
36413	SUPPL	2014-11-18
27135	SUPPL	2014-10-27
36412	SUPPL	2013-08-06
4698	SUPPL	2013-08-05
14678	SUPPL	2013-01-11
4699	SUPPL	2013-01-10
27134	SUPPL	2012-05-02
4697	SUPPL	2010-11-02
36411	SUPPL	2010-10-25
4696	SUPPL	2010-02-05
14677	SUPPL	2010-02-04
27132	SUPPL	2009-06-30
14676	SUPPL	2009-06-29
27133	SUPPL	2009-05-07
36410	SUPPL	2008-08-13
21525	SUPPL	2008-07-31
4694	SUPPL	2008-07-31
4695	SUPPL	2008-07-24
51284	SUPPL	2007-08-15
36409	SUPPL	2005-02-17
27131	SUPPL	2005-02-17
36407	SUPPL	2004-10-04
27130	SUPPL	2004-10-04
4691	SUPPL	2004-05-28
36408	SUPPL	2004-04-05
14675	SUPPL	2004-04-05
4693	SUPPL	2004-03-24
4692	SUPPL	2004-03-24
36406	SUPPL	2003-03-07
36405	SUPPL	2002-11-21
27129	SUPPL	2002-11-21
36404	SUPPL	2002-09-20
27128	SUPPL	2002-09-20
14674	SUPPL	2002-09-20
4690	SUPPL	2002-09-20
42039	ORIG	2001-01-26
14673	ORIG	2001-01-26
4689	ORIG	2001-01-26
58103	ORIG	1900-01-01
54102	ORIG	1900-01-01
54101	ORIG	1900-01-01
54100	ORIG	1900-01-01