Application 209489

Type: ANDA
Sponsor: CIPLA

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 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
A209489-001	CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS			2018-07-12
A209489-002	CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS			2018-07-12

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209489-001	CASPOFUNGIN ACETATE	50MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209489-002	CASPOFUNGIN ACETATE	70MG/VIAL	POWDER / INTRAVENOUS	2018-07-12	`3a93d1ddd44b…`

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 · 7 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 brand name: Caspofungin Acetate 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 brand name: Caspofungin Acetate 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 brand name: CASPOFUNGIN ACETATE generic name: CASPOFUNGIN ACETATE
CANCIDAS	CASPOFUNGIN ACETATE	Merck Sharp & Dohme LLC	3bad23a6-09a6-4194-9182-093ed61bc71c	2024-10-11	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 brand name: Caspofungin Acetate generic name: CASPOFUNGIN ACETATE
CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE	Sandoz Inc	722facc6-d4ea-4975-b83e-3ae63df69ed2	2022-01-31	Warnings, Adverse reactions	Name fallback brand name: CASPOFUNGIN ACETATE generic name: CASPOFUNGIN ACETATE
Caspofungin Acetate	CASPOFUNGIN ACETATE	Gland Pharma Limited	29da357e-e7fc-46af-bf20-806a1e4b5391	2022-01-19	Warnings, Adverse reactions	Name fallback brand name: Caspofungin Acetate 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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69097-365	caspofungin acetate	caspofungin acetate	Cipla USA Inc.	ANDA	Current
69097-365	caspofungin acetate	caspofungin acetate	Cipla USA Inc.	ANDA	Current
69097-366	caspofungin acetate	caspofungin acetate	Cipla USA Inc.	ANDA	Current
69097-366	caspofungin acetate	caspofungin acetate	Cipla USA Inc.	ANDA	Current