Application 020863

Type: NDA
Sponsor: OTSUKA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PLETAL	CILOSTAZOL	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	PLETAL	CILOSTAZOL	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020863-001	PLETAL	CILOSTAZOL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1999-01-15
N020863-002	PLETAL	CILOSTAZOL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1999-01-15

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-01-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-01-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-01-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-01-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-01-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-01-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-01-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-01-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-01-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-01-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-01-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-01-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-01-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-01-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-01-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-01-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-01-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1999-01-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020863-001	PLETAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020863-002	PLETAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-01-15	`3a93d1ddd44b…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cilostazol	CILOSTAZOL	Apotex Corp.	ceac1ae3-c343-28ca-c083-b748d21a15e6	2026-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CILOSTAZOL
cilostazol	CILOSTAZOL	AvKARE	dc7c2c25-36a1-e3fd-e053-2995a90adabc	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CILOSTAZOL
cilostazol	CILOSTAZOL	AvPAK	aec462c8-e225-f520-cae5-80049151c0ff	2026-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CILOSTAZOL
Cilostazol	CILOSTAZOL	Slate Run Pharmaceuticals, LLC	db0278e9-4ece-4aaf-9216-6bcbec58206a	2025-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CILOSTAZOL
Cilostazol	CILOSTAZOL	Chartwell RX, LLC	77e77eaf-5556-43ac-844e-c0e29f02fe07	2025-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CILOSTAZOL
CILOSTAZOL	CILOSTAZOL	direct rx	b57d3c1e-e36f-5255-e053-2a95a90ada83	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CILOSTAZOL
Cilostazol	CILOSTAZOL	Bryant Ranch Prepack	f728395c-684c-4087-a389-c323dbcb72dd	2024-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CILOSTAZOL
cilostazol	CILOSTAZOL	Aphena Pharma Solutions - Tennessee, LLC	15ead884-bd4f-7f4b-e063-6394a90a8f81	2024-04-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CILOSTAZOL
cilostazol	CILOSTAZOL	Aphena Pharma Solutions - Tennessee, LLC	15478d90-312f-014e-e063-6294a90ae838	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CILOSTAZOL
Cilostazol	CILOSTAZOL	Bryant Ranch Prepack	53486382-eee0-4cbe-bc4a-a57484e0d5a7	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CILOSTAZOL
Cilostazol	CILOSTAZOL	Teva Pharmaceuticals USA, Inc.	a6292311-9cb2-49ff-b8bf-12e2dbd196cd	2022-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CILOSTAZOL

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
48454	SUPPL	2017-05-19
48449	SUPPL	2017-05-18
13637	SUPPL	2015-08-04
26076	SUPPL	2015-07-31
13636	SUPPL	2015-01-29
26075	SUPPL	2015-01-26
13635	SUPPL	2007-11-19
3601	SUPPL	2007-11-19
26074	SUPPL	2007-01-25
13634	SUPPL	2007-01-24
35526	SUPPL	2005-11-30
26073	SUPPL	2005-11-30
13633	ORIG	2004-06-14
3600	SUPPL	2004-03-03
21027	ORIG	1999-01-15
3599	ORIG	1999-01-15