Application 074290

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ETOPOSIDE	ETOPOSIDE	INJECTABLE;INJECTION	20MG/ML	No	No

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

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
A074290-001	ETOPOSIDE	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP		1995-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074290-001	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.

Product history page 1 of 2 · 42 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
2026-08-18 06:07:40	2026-07	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074290-001	ETOPOSIDE	20MG/ML	INJECTABLE / INJECTION	AP	1995-07-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074290-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074290-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074290-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074290-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074290-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074290-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074290-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074290-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074290-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074290-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074290-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074290-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074290-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074290-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074290-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074290-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074290-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074290-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074290-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074290-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074290-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074290-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074290-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074290-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074290-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074290-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074290-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074290-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074290-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074290-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074290-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074290-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074290-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074290-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074290-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074290-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074290-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074290-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074290-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074290-001	AP	1	`e64feba35796…`

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	Hikma Pharmaceuticals USA Inc.	e0cd61b9-2375-4e3d-a610-d87dad962468	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074290 application number: ANDA074290 ndc (product): 0143-9376
Etoposide	ETOPOSIDE	Hikma Pharmaceuticals USA Inc.	6dfedeff-a807-4405-a482-2f7109ad31c9	2023-09-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074290 application number: ANDA074290 ndc (product): 0143-9511 ndc (product): 0143-9510 ndc (product): 0143-9512

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9376	Etoposide	Etoposide	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9510	Etoposide	Etoposide	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9510	Etoposide	Etoposide	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9511	Etoposide	Etoposide	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9511	Etoposide	Etoposide	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9512	Etoposide	Etoposide	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9512	Etoposide	Etoposide	Hikma Pharmaceuticals USA Inc.	ANDA	Current