Application 020623

Type: NDA
Sponsor: US PHARM HOLDINGS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ANZEMET	DOLASETRON MESYLATE	TABLET;ORAL	50MG	Yes	No
002	ANZEMET	DOLASETRON MESYLATE	TABLET;ORAL	100MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020623-001	ANZEMET	DOLASETRON MESYLATE	50MG	TABLET / ORAL		RLD	1997-09-11
N020623-002	ANZEMET	DOLASETRON MESYLATE	100MG	TABLET / ORAL		RLD	1997-09-11

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 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD	1997-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD	1997-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD	1997-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD	1997-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD	1997-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD	1997-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD	1997-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD	1997-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD	1997-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD	1997-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD	1997-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD	1997-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD, RS	1997-09-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD, RS	1997-09-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD, RS	1997-09-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD, RS	1997-09-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD, RS	1997-09-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD	1997-09-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD, RS	1997-09-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020623-001	ANZEMET	50MG	TABLET / ORAL	RLD	1997-09-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020623-002	ANZEMET	100MG	TABLET / ORAL	RLD	1997-09-11	`782e0a99824c…`

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
30698-120	ANZEMET	dolasetron mesylate	Validus Pharmaceuticals LLC	NDA	Current
30698-121	ANZEMET	dolasetron mesylate	Validus Pharmaceuticals LLC	NDA	Current
30698-220	ANZEMET	dolasetron mesylate	Validus Pharmaceuticals LLC	NDA	Current
30698-220	ANZEMET	dolasetron mesylate	Validus Pharmaceuticals LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
2895	SUPPL	2014-09-23
12859	SUPPL	2014-09-22
25334	SUPPL	2013-09-17
34969	SUPPL	2013-09-16
34968	SUPPL	2011-09-28
2894	SUPPL	2011-09-27
41486	ORIG	2010-03-03
25333	SUPPL	2009-11-10
12858	SUPPL	2009-10-14
25332	SUPPL	2007-09-26
12857	SUPPL	2007-06-04
2893	SUPPL	2007-06-04
34967	SUPPL	2005-06-07
2892	SUPPL	2005-06-07