Application 019557

Type: NDA
Sponsor: DAVA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VEPESID	ETOPOSIDE	CAPSULE;ORAL	50MG	Yes	No
002	VEPESID	ETOPOSIDE	CAPSULE;ORAL	100MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N019557-001	VEPESID	ETOPOSIDE	50MG	CAPSULE / ORAL	AB	RLD	1986-12-30
N019557-002	VEPESID	ETOPOSIDE	100MG	CAPSULE / ORAL		RLD	1986-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019557-001	AB

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019557-001	VEPESID	50MG	CAPSULE / ORAL	AB	RLD	1986-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019557-001	VEPESID	50MG	CAPSULE / ORAL	AB	RLD	1986-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019557-001	VEPESID	50MG	CAPSULE / ORAL		RLD	1986-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019557-001	VEPESID	50MG	CAPSULE / ORAL		RLD	1986-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019557-001	VEPESID	50MG	CAPSULE / ORAL		RLD	1986-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019557-001	VEPESID	50MG	CAPSULE / ORAL		RLD	1986-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019557-001	VEPESID	50MG	CAPSULE / ORAL		RLD	1986-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019557-001	VEPESID	50MG	CAPSULE / ORAL		RLD	1986-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019557-001	VEPESID	50MG	CAPSULE / ORAL		RLD	1986-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019557-001	VEPESID	50MG	CAPSULE / ORAL		RLD	1986-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019557-001	VEPESID	50MG	CAPSULE / ORAL		RLD	1986-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019557-001	VEPESID	50MG	CAPSULE / ORAL		RLD	1986-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019557-001	VEPESID	50MG	CAPSULE / ORAL		RLD	1986-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019557-001	VEPESID	50MG	CAPSULE / ORAL		RLD	1986-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019557-001	VEPESID	50MG	CAPSULE / ORAL		RLD	1986-12-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019557-001	VEPESID	50MG	CAPSULE / ORAL		RLD	1986-12-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019557-001	VEPESID	50MG	CAPSULE / ORAL		RLD	1986-12-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019557-001	VEPESID	50MG	CAPSULE / ORAL		RLD	1986-12-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019557-001	VEPESID	50MG	CAPSULE / ORAL		RLD	1986-12-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019557-001	VEPESID	50MG	CAPSULE / ORAL		RLD	1986-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019557-002	VEPESID	100MG	CAPSULE / ORAL		RLD	1986-12-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N019557-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019557-001	AB	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019557-001	AB	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ETOPOSIDE	ETOPOSIDE	Onesource Specialty Pharma Limited	7bc994df-ee84-4ed7-80fa-737f70918953	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019557 application number: NDA019557
VePesid	ETOPOSIDE	Amneal Pharmaceuticals NY LLC	2a40f3ed-4a36-4616-af6c-b616140fd5ee	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019557 application number: NDA019557

Documents#

Document, Submission type, Date table
Document	Submission type	Date
11529	SUPPL	2012-08-03
40936	SUPPL	2007-07-06
17453	SUPPL	2002-11-05
20261	SUPPL	1999-04-02