Application 209965

Type: ANDA
Sponsor: MSN

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
A209965-001	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
A209965-001	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.

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	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209965-001	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	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209965-001	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	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209965-001	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	A209965-001	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	A209965-001	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	A209965-001	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	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209965-001	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	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209965-001	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	A209965-001	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	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	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
2026-02-19 14:30 UTC	2026-02	A209965-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209965-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209965-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209965-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209965-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209965-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209965-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209965-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209965-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209965-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209965-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209965-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209965-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209965-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209965-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209965-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209965-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209965-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209965-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209965-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209965-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209965-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209965-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209965-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209965-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209965-001	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209965-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209965-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209965-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209965-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209965-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209965-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209965-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209965-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209965-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209965-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209965-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209965-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209965-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209965-001	AP	1	`a50c72e98297…`

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
Fosaprepitant	FOSAPREPITANT	Northstar Rx LLC	bf207918-100d-4917-88b0-3433c0e72249	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209965 application number: ANDA209965
Fosaprepitant	FOSAPREPITANT	Bryant Ranch Prepack	679c195a-cf59-4ca5-aa05-fa35d08ddb5c	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209965 application number: ANDA209965
Fosaprepitant	FOSAPREPITANT	BluePoint Laboratories	ad89825f-aa31-469f-9685-159a4524dfdc	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209965 application number: ANDA209965
Fosaprepitant	FOSAPREPITANT	Dr. Reddy's Laboratories Inc.,	f34c931c-78b9-90c1-3fa5-bb34a227f2ad	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209965 application number: ANDA209965 ndc (product): 43598-859
Fosaprepitant	FOSAPREPITANT	Novadoz Pharmaceuticals LLC	1e6b36b2-3c8b-4ac4-827e-d6f00d999032	2022-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209965 application number: ANDA209965 ndc (product): 72205-054
Fosaprepitant	FOSAPREPITANT	Novadoz Pharmaceuticals LLC	a7343abe-b2b0-4e5a-907b-532a8e16dfcb	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209965 application number: ANDA209965 ndc (product): 72205-083
Fosaprepitant	FOSAPREPITANT	Dr. Reddy's Laboratories Inc.,	d624667d-ee3b-3501-53fe-da453352042d	2020-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209965 application number: ANDA209965 ndc (product): 43598-948

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-120	Fosaprepitant	Fosaprepitant	NorthStar RxLLC	ANDA	Current
16714-929	Fosaprepitant	Fosaprepitant	NorthStar RxLLC	ANDA	Current
16714-929	Fosaprepitant	Fosaprepitant	NorthStar RxLLC	ANDA	Current
16714-929	Fosaprepitant	Fosaprepitant	NorthStar RxLLC	ANDA	Current
43598-859	Fosaprepitant	Fosaprepitant	Dr. Reddy's Laboratories Inc.,	ANDA	Current
43598-948	Fosaprepitant	Fosaprepitant	Dr. Reddy's Laboratories Inc.,	ANDA	Current
69539-034	Fosaprepitant	Fosaprepitant	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-034	Fosaprepitant	Fosaprepitant	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-181	Fosaprepitant	Fosaprepitant	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-181	Fosaprepitant	Fosaprepitant	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
72205-026	Fosaprepitant	Fosaprepitant	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-054	Fosaprepitant	Fosaprepitant	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-083	Fosaprepitant	Fosaprepitant	Novadoz Pharmaceuticals LLC	ANDA	Current