Application 077722

Type: ANDA
Sponsor: CHARTWELL RX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CILOSTAZOL	CILOSTAZOL	TABLET;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077722-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2012-09-24	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077722-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2012-09-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077722-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2012-09-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077722-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2012-09-24	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077722-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077722-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077722-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077722-001	AB	1	`ea99ee380514…`

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 brand name: cilostazol generic name: CILOSTAZOL
cilostazol	CILOSTAZOL	AvKARE	dc7c2c25-36a1-e3fd-e053-2995a90adabc	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: cilostazol generic name: CILOSTAZOL
cilostazol	CILOSTAZOL	AvPAK	aec462c8-e225-f520-cae5-80049151c0ff	2026-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: cilostazol generic name: CILOSTAZOL
Cilostazol	CILOSTAZOL	Slate Run Pharmaceuticals, LLC	db0278e9-4ece-4aaf-9216-6bcbec58206a	2025-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Cilostazol generic name: CILOSTAZOL
Cilostazol	CILOSTAZOL	Chartwell RX, LLC	77e77eaf-5556-43ac-844e-c0e29f02fe07	2025-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Cilostazol generic name: CILOSTAZOL
CILOSTAZOL	CILOSTAZOL	direct rx	b57d3c1e-e36f-5255-e053-2a95a90ada83	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CILOSTAZOL generic name: CILOSTAZOL
Cilostazol	CILOSTAZOL	Bryant Ranch Prepack	f728395c-684c-4087-a389-c323dbcb72dd	2024-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Cilostazol 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 brand name: cilostazol 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 brand name: cilostazol generic name: CILOSTAZOL
Cilostazol	CILOSTAZOL	Bryant Ranch Prepack	53486382-eee0-4cbe-bc4a-a57484e0d5a7	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Cilostazol generic name: CILOSTAZOL
Cilostazol	CILOSTAZOL	Teva Pharmaceuticals USA, Inc.	a6292311-9cb2-49ff-b8bf-12e2dbd196cd	2022-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Cilostazol generic name: CILOSTAZOL

Reported adverse events (FAERS/openFDA)#

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