Application 021991

Type: NDA
Sponsor: MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOLINZA	VORINOSTAT	CAPSULE;ORAL	100MG	Yes	Yes

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
N021991-001	ZOLINZA	VORINOSTAT	100MG	CAPSULE / ORAL		RLD, RS	2006-10-06

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021991-001	8093295	2026-05-16		Drug product
N021991-001	7456219	2027-03-11		Drug substance
N021991-001	8450372	2028-03-18	U-892		2013-06-14

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL	RLD, RS	2006-10-06	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 296 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021991-001	8093295	2026-05-16		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021991-001	7456219	2027-03-11		Drug substance		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021991-001	8450372	2028-03-18	U-892		2013-06-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021991-001	8093295	2026-05-16		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021991-001	7456219	2027-03-11		Drug substance		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021991-001	8450372	2028-03-18	U-892		2013-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021991-001	7399787	2025-02-09	U-892			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021991-001	8093295	2026-05-16		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021991-001	7456219	2027-03-11		Drug substance		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021991-001	8450372	2028-03-18	U-892		2013-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021991-001	7399787	2025-02-09	U-892			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021991-001	8093295	2026-05-16		Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021991-001	7456219	2027-03-11		Drug substance		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021991-001	8450372	2028-03-18	U-892		2013-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021991-001	7399787	2025-02-09	U-892			`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021991-001	8093295	2026-05-16		Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021991-001	7456219	2027-03-11		Drug substance		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021991-001	8450372	2028-03-18	U-892		2013-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021991-001	7399787	2025-02-09	U-892			`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021991-001	8093295	2026-05-16		Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021991-001	7456219	2027-03-11		Drug substance		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021991-001	8450372	2028-03-18	U-892		2013-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021991-001	7851509	2024-02-21	U-892	Drug product	2010-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021991-001	7399787	2025-02-09	U-892			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021991-001	8093295	2026-05-16		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021991-001	7456219	2027-03-11		Drug substance		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021991-001	8450372	2028-03-18	U-892		2013-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021991-001	7851509	2024-02-21	U-892	Drug product	2010-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021991-001	7399787	2025-02-09	U-892			`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021991-001	8093295	2026-05-16		Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021991-001	7456219	2027-03-11		Drug substance		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021991-001	8450372	2028-03-18	U-892		2013-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021991-001	7851509	2024-02-21	U-892	Drug product	2010-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021991-001	7399787	2025-02-09	U-892			`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021991-001	8093295	2026-05-16		Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021991-001	7456219	2027-03-11		Drug substance		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021991-001	8450372	2028-03-18	U-892		2013-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021991-001	7851509	2024-02-21	U-892	Drug product	2010-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021991-001	7399787	2025-02-09	U-892			`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021991-001	8093295	2026-05-16		Drug product		`d8e5a09893c0…`

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
ZOLINZA	VORINOSTAT	Merck Sharp & Dohme LLC	cd86ee78-2781-468b-930c-3c4677bcc092	2024-11-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021991 application number: NDA021991 ndc (product): 0006-0568

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-0568	ZOLINZA	vorinostat	Merck Sharp & Dohme Corp.	NDA	Current
0006-0568	ZOLINZA	vorinostat	Merck Sharp & Dohme LLC	NDA	Current
0006-0568	ZOLINZA	vorinostat	Merck Sharp & Dohme LLC	NDA	Current
0006-0568	ZOLINZA	vorinostat	Merck Sharp & Dohme LLC	NDA	Current
0006-0568	ZOLINZA	vorinostat	Merck Sharp & Dohme Corp.	NDA	Current
0006-0568	ZOLINZA	vorinostat	Merck Sharp & Dohme Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56842	SUPPL	2018-12-20
56711	SUPPL	2018-12-12
6610	SUPPL	2015-12-22
28993	SUPPL	2011-11-17
38012	SUPPL	2011-11-15
6609	SUPPL	2011-06-17
28994	SUPPL	2009-11-10
38013	SUPPL	2009-10-01
6608	SUPPL	2008-07-24
16704	SUPPL	2008-07-23
21897	ORIG	2006-11-20
6607	ORIG	2006-10-13
16703	ORIG	2006-10-11