Application 204015

Type: ANDA
Sponsor: MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	POWDER;INTRAVENOUS	EQ 115MG BASE/VIAL	No	No
002	FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	POWDER;INTRAVENOUS	EQ 150MG BASE/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
A204015-001	FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS			2019-09-05
A204015-002	FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2019-09-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204015-002	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 2 of 3 · 86 observed 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
2019-12-13 00:20 UTC	2019-12	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204015-002	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	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204015-002	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	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A204015-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204015-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204015-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204015-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204015-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204015-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204015-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204015-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204015-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204015-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204015-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204015-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204015-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204015-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204015-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204015-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204015-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204015-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204015-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204015-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204015-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204015-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204015-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204015-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204015-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204015-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204015-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204015-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204015-002	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204015-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204015-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204015-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204015-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204015-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204015-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204015-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204015-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204015-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204015-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204015-002	AP	1	`f41ea6bd6efb…`

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	Mylan Institutional LLC	9b6d5ea3-2f7a-4501-9a4a-6fa1a7c2d50a	2026-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204015 application number: ANDA204015 ndc (product): 67457-889

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
67457-888	fosaprepitant	fosaprepitant	Mylan Institutional LLC	ANDA	Current
67457-888	fosaprepitant	fosaprepitant	Mylan Institutional LLC	ANDA	Current
67457-889	fosaprepitant	fosaprepitant	Mylan Institutional LLC	ANDA	Current
67457-889	fosaprepitant	fosaprepitant	Mylan Institutional LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60235	ORIG	2019-10-04