Application 020457

Type: NDA
Sponsor: CHEPLAPHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ETOPOPHOS PRESERVATIVE FREE	ETOPOSIDE PHOSPHATE	INJECTABLE;INJECTION	EQ 100MG BASE/VIAL	Yes	Yes

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
N020457-001	ETOPOPHOS PRESERVATIVE FREE	ETOPOSIDE PHOSPHATE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS	1996-05-17

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 2 · 41 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	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020457-001	ETOPOPHOS PRESERVATIVE FREE	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1996-05-17	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ETOPOPHOS	ETOPOSIDE PHOSPHATE	H2-Pharma, LLC	7499fc35-fae8-44ad-bbab-9a1a589bf3ee	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020457 application number: NDA020457 ndc (product): 61269-410

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0015-3404	ETOPOPHOS	etoposide phosphate	E.R. Squibb & Sons, L.L.C.	NDA	Current
0015-3404	ETOPOPHOS	etoposide phosphate	E.R. Squibb & Sons, L.L.C	NDA	Current
0015-3404	ETOPOPHOS	etoposide phosphate	E.R. Squibb & Sons, L.L.C.	NDA	Current
0015-3404	ETOPOPHOS	etoposide phosphate	E.R. Squibb & Sons, L.L.C.	NDA	Current
0015-3404	ETOPOPHOS	etoposide phosphate	E.R. Squibb & Sons, L.L.C.	NDA	Current
61269-410	ETOPOPHOS	etoposide phosphate	H2-Pharma, LLC	NDA	Current
61269-410	ETOPOPHOS	etoposide phosphate	H2-Pharma, LLC	NDA	Current
61269-410	ETOPOPHOS	etoposide phosphate	H2-Pharma, LLC	NDA	Current
61269-410	ETOPOPHOS	etoposide phosphate	H2-Pharma, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58557	SUPPL	2019-05-03
58545	SUPPL	2019-05-03
48539	SUPPL	2017-05-25
45898	SUPPL	2016-11-16
45894	SUPPL	2016-11-15
34676	SUPPL	2015-08-04
2564	SUPPL	2015-07-31
24997	SUPPL	2011-03-21
12607	SUPPL	2011-03-21
24996	SUPPL	2002-11-05
24995	SUPPL	2002-02-21
24994	SUPPL	2002-02-21