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 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
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.

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
2026-08-01 22:54:32	2026-06	N021991-001	ZOLINZA	100MG	CAPSULE / ORAL		RLD, RS	2006-10-06	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N021991-001	8093295	2026-05-16		Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021991-001	7456219	2027-03-11		Drug substance		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021991-001	8450372	2028-03-18	U-892		2013-06-14	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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