Application 017588

Type: NDA
Sponsor: CORDEN PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLEOSTINE	LOMUSTINE	CAPSULE;ORAL	10MG	Yes	No
002	GLEOSTINE	LOMUSTINE	CAPSULE;ORAL	40MG	Yes	No
003	GLEOSTINE	LOMUSTINE	CAPSULE;ORAL	100MG	Yes	Yes
004	GLEOSTINE	LOMUSTINE	CAPSULE;ORAL	5MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017588-001	GLEOSTINE	LOMUSTINE	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982
N017588-002	GLEOSTINE	LOMUSTINE	40MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982
N017588-003	GLEOSTINE	LOMUSTINE	100MG	CAPSULE / ORAL	AB	RLD, Approved before 1982
N017588-004	GLEOSTINE	LOMUSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N017588-001	AB
N017588-002	AB
N017588-003	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 5 · 168 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	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL		RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL		RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL		RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL		RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL		RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL		RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL		RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`d8e5a09893c0…`

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	N017588-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017588-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017588-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017588-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017588-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017588-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017588-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017588-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017588-003	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017588-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017588-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017588-003	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lomustine	LOMUSTINE	Wilshire Pharmaceuticals, Inc.	3c3637fc-4499-4331-a3c4-6969fc86704e	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017588 application number: NDA017588
Gleostine	LOMUSTINE	Azurity Pharmaceuticals, Inc.	3529fe2f-3c23-4862-bb20-b48026957082	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017588 application number: NDA017588
Gleostine	LOMUSTINE	NextSource Biotechnology, LLC	7f77526b-4c40-409c-82ea-d0f934d89cc2	2024-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017588 application number: NDA017588 ndc (product): 58181-3040 ndc (product): 58181-3042 ndc (product): 58181-3041

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
58181-3040	Gleostine	lomustine	NextSource Biotechnology, LLC	NDA	Current
58181-3040	Gleostine	lomustine	NextSource Biotechnology, LLC	NDA	Current
58181-3040	Gleostine	lomustine	NextSource Biotechnology, LLC	NDA	Current
58181-3041	Gleostine	lomustine	NextSource Biotechnology, LLC	NDA	Current
58181-3041	Gleostine	lomustine	NextSource Biotechnology, LLC	NDA	Current
58181-3041	Gleostine	lomustine	NextSource Biotechnology, LLC	NDA	Current
58181-3042	Gleostine	lomustine	NextSource Biotechnology, LLC	NDA	Current
58181-3042	Gleostine	lomustine	NextSource Biotechnology, LLC	NDA	Current
58181-3042	Gleostine	lomustine	NextSource Biotechnology, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64854	SUPPL	2020-10-06
63588	SUPPL	2020-06-17
33317	SUPPL	2016-02-02
13864	SUPPL	2016-02-01
11042	SUPPL	2016-01-07
661	SUPPL	2016-01-07
33316	SUPPL	2014-05-28
660	SUPPL	2014-05-22
11041	SUPPL	2013-08-21
11040	SUPPL	2012-11-28
658	SUPPL	2012-11-23
33315	SUPPL	2011-05-16
659	SUPPL	2011-05-16
33314	SUPPL	2009-05-11
657	SUPPL	2009-05-06
656	SUPPL	2003-03-10
655	SUPPL	2002-12-20