Application 212957

Type: ANDA
Sponsor: NAVINTA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	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
A212957-002	FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS			2020-08-20

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	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2020-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2020-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2020-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2020-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2020-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2020-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2020-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2020-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2020-08-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212957-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS		2020-08-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212957-002	AP	1	`5bbf6a4d5a75…`
2024-10-29 15:01 UTC	2024-10	A212957-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212957-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212957-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212957-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212957-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212957-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212957-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212957-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212957-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212957-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212957-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212957-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212957-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212957-002	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212957-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212957-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212957-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212957-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212957-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212957-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212957-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212957-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212957-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212957-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212957-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212957-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212957-002	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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fosaprepitant	FOSAPREPITANT DIMEGLUMINE	Baxter Healthcare Corporation	3ed3e0a9-a0a8-4555-9f73-2043e79e3398	2026-05-29	Warnings, Adverse reactions	Name fallback generic name: FOSAPREPITANT DIMEGLUMINE
FOCINVEZ	FOSAPREPITANT DIMEGLUMINE	Amneal Pharmaceuticals LLC	7afe33d8-5416-465a-b98b-f4eedc327a94	2026-04-17	Warnings, Adverse reactions	Name fallback generic name: FOSAPREPITANT DIMEGLUMINE
Fosaprepitant	FOSAPREPITANT DIMEGLUMINE	Camber Pharmaceuticals, Inc.	7dbdf8f5-6936-4143-b52d-96774b799a7d	2026-04-14	Warnings, Adverse reactions	Name fallback generic name: FOSAPREPITANT DIMEGLUMINE
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	Eugia US LLC	19919480-960b-4741-9611-c133d68512f5	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: FOSAPREPITANT DIMEGLUMINE generic name: FOSAPREPITANT DIMEGLUMINE
FOCINVEZ	FOSAPREPITANT DIMEGLUMINE	Steriscience Specialties Private Limited	18a60093-cec8-1b8c-e063-6394a90a8902	2026-03-30	Warnings, Adverse reactions	Name fallback generic name: FOSAPREPITANT DIMEGLUMINE
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	Hikma Pharmaceuticals USA Inc.	1a7d2f44-b578-4d99-a4ff-f267626064d0	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: FOSAPREPITANT DIMEGLUMINE generic name: FOSAPREPITANT DIMEGLUMINE
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	Hikma Pharmaceuticals USA Inc.	1cc7d482-5d45-4621-9ffc-cd3f7c54614d	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: FOSAPREPITANT DIMEGLUMINE generic name: FOSAPREPITANT DIMEGLUMINE
EMEND	FOSAPREPITANT DIMEGLUMINE	Merck Sharp & Dohme LLC	8d66803a-6811-4c29-9c57-e16acfa87f21	2026-02-20	Warnings, Adverse reactions	Name fallback generic name: FOSAPREPITANT DIMEGLUMINE
FOSAPREPITANT	FOSAPREPITANT DIMEGLUMINE	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	7375ab3f-a6fc-4601-9415-07b4f681cdef	2025-12-24	Warnings, Adverse reactions	Name fallback generic name: FOSAPREPITANT DIMEGLUMINE
FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	Qilu Pharmaceutical Co., Ltd.	5bb41bcb-c775-4447-9bd0-d4c55ad110ea	2025-08-07	Warnings, Adverse reactions	Name fallback brand name: FOSAPREPITANT DIMEGLUMINE generic name: FOSAPREPITANT DIMEGLUMINE
Fosaprepitant	FOSAPREPITANT DIMEGLUMINE	Avenacy, LLC	3f942e4c-e26a-4155-9e14-344b2970b189	2025-07-09	Warnings, Adverse reactions	Name fallback generic name: FOSAPREPITANT DIMEGLUMINE
Fosaprepitant	FOSAPREPITANT DIMEGLUMINE	BluePoint Laboratories	2d30d839-bb88-46ce-a9ed-66fe32a12a7a	2025-07-07	Warnings, Adverse reactions	Name fallback generic name: FOSAPREPITANT DIMEGLUMINE
Fosaprepitant	FOSAPREPITANT DIMEGLUMINE	NorthStar RxLLC	df341f63-0fef-4411-a89b-6df6b9e792be	2023-07-25	Warnings, Adverse reactions	Name fallback generic name: FOSAPREPITANT DIMEGLUMINE

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
70710-1615	fosaprepitant	fosaprepitant	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1615	fosaprepitant	fosaprepitant	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1615	fosaprepitant	fosaprepitant	Zydus Pharmaceuticals USA Inc.	ANDA	Current