Application 205020

Type: ANDA
Sponsor: APOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	POWDER;INTRAVENOUS	EQ 150MG 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205020-001	FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS			2019-09-05

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	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205020-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205020-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205020-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205020-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205020-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205020-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205020-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205020-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205020-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205020-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205020-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205020-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205020-001	AP	1	`b00525d2431f…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205020-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205020-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205020-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205020-001	AP	1	`cb3db0bc1861…`

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
Fosaprepitant	FOSAPREPITANT	BluePoint Laboratories	46edae30-d50c-4112-9941-954b13ed5eda	2024-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205020 application number: ANDA205020 ndc (product): 68001-421

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-6105	Fosaprepitant	Fosaprepitant	Apotex Corp	ANDA	Current
60505-6105	Fosaprepitant	Fosaprepitant	Apotex Corp	ANDA	Current
68001-421	Fosaprepitant	Fosaprepitant	BluePoint Laboratories	ANDA	Current