Application 077841

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PENTOSTATIN	PENTOSTATIN	INJECTABLE;INJECTION	10MG/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077841-001	PENTOSTATIN	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP		2007-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077841-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077841-001	PENTOSTATIN	10MG/VIAL	INJECTABLE / INJECTION	AP	2007-08-07	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A077841-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077841-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077841-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nipent	PENTOSTATIN	Hospira, Inc.	674e0e6d-46ed-4868-9196-04019d667716	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PENTOSTATIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9088	ORIG	2007-08-14