Application 077027

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CILOSTAZOL	CILOSTAZOL	TABLET;ORAL	50MG	No	Yes
002	CILOSTAZOL	CILOSTAZOL	TABLET;ORAL	100MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077027-001	CILOSTAZOL	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24
A077027-002	CILOSTAZOL	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077027-001	AB
A077027-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077027-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077027-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077027-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077027-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077027-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077027-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077027-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077027-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077027-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077027-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077027-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077027-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077027-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077027-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077027-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077027-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077027-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077027-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077027-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077027-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077027-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077027-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077027-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077027-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077027-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077027-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077027-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077027-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077027-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077027-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077027-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077027-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077027-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077027-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077027-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077027-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077027-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077027-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077027-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077027-002	AB	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CILOSTAZOL	CILOSTAZOL	direct rx	b57d3c1e-e36f-5255-e053-2a95a90ada83	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077027 application number: ANDA077027 ndc (product): 72189-116
Cilostazol	CILOSTAZOL	Bryant Ranch Prepack	f728395c-684c-4087-a389-c323dbcb72dd	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077027 application number: ANDA077027 ndc (product): 63629-8796
Cilostazol	CILOSTAZOL	Bryant Ranch Prepack	53486382-eee0-4cbe-bc4a-a57484e0d5a7	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077027 application number: ANDA077027 ndc (product): 63629-8795
Cilostazol	CILOSTAZOL	Teva Pharmaceuticals USA, Inc.	a6292311-9cb2-49ff-b8bf-12e2dbd196cd	2022-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077027 application number: ANDA077027 ndc (product): 0093-2065 ndc (product): 0093-2064

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-2064	Cilostazol	Cilostazol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2064	Cilostazol	Cilostazol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2064	Cilostazol	Cilostazol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2064	Cilostazol	Cilostazol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2064	Cilostazol	Cilostazol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2064	Cilostazol	Cilostazol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2065	Cilostazol	Cilostazol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2065	Cilostazol	Cilostazol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2065	Cilostazol	Cilostazol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2065	Cilostazol	Cilostazol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2065	Cilostazol	Cilostazol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2065	Cilostazol	Cilostazol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0615-7713	Cilostazol	Cilostazol	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7716	Cilostazol	Cilostazol	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7747	Cilostazol	Cilostazol	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
50090-5329	Cilostazol	Cilostazol	A-S Medication Solutions	ANDA	Current
50090-5329	Cilostazol	Cilostazol	A-S Medication Solutions	ANDA	Current
63629-8795	Cilostazol	Cilostazol	Bryant Ranch Prepack	ANDA	Current
63629-8795	Cilostazol	Cilostazol	Bryant Ranch Prepack	ANDA	Current
63629-8795	Cilostazol	Cilostazol	Bryant Ranch Prepack	ANDA	Current
63629-8796	Cilostazol	Cilostazol	Bryant Ranch Prepack	ANDA	Current
63629-8796	Cilostazol	Cilostazol	Bryant Ranch Prepack	ANDA	Current
63629-8796	Cilostazol	Cilostazol	Bryant Ranch Prepack	ANDA	Current
68071-2052	Cilostazol	Cilostazol	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4125	Cilostazol	Cilostazol	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-2200	Cilostazol	Cilostazol	REMEDYREPACK INC.	ANDA	Current
70518-2200	Cilostazol	Cilostazol	REMEDYREPACK INC.	ANDA	Current
70518-2200	Cilostazol	Cilostazol	REMEDYREPACK INC.	ANDA	Current
70518-2208	Cilostazol	Cilostazol	REMEDYREPACK INC.	ANDA	Current
70518-2208	Cilostazol	Cilostazol	REMEDYREPACK INC.	ANDA	Current
70518-2208	Cilostazol	Cilostazol	REMEDYREPACK INC.	ANDA	Current
72189-116	CILOSTAZOL	CILOSTAZOL	direct rx	ANDA	Current