Application 077030

Type: ANDA
Sponsor: APOTEX INC

Application Products#

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

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
A077030-001	CILOSTAZOL	CILOSTAZOL	50MG	TABLET / ORAL	AB		2004-12-10
A077030-002	CILOSTAZOL	CILOSTAZOL	100MG	TABLET / ORAL	AB		2004-12-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077030-001	AB
A077030-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`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	A077030-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077030-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077030-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077030-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077030-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077030-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077030-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077030-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077030-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077030-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077030-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077030-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077030-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077030-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077030-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077030-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077030-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077030-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077030-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077030-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077030-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077030-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077030-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077030-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077030-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077030-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077030-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077030-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077030-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077030-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077030-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077030-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077030-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077030-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077030-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077030-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077030-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077030-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077030-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077030-002	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cilostazol	CILOSTAZOL	AvKARE	dc7c2c25-36a1-e3fd-e053-2995a90adabc	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077030 application number: ANDA077030 ndc (product): 42291-453
cilostazol	CILOSTAZOL	AvPAK	aec462c8-e225-f520-cae5-80049151c0ff	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077030 application number: ANDA077030 ndc (product): 50268-177 ndc (product): 50268-176
cilostazol	CILOSTAZOL	Apotex Corp.	ceac1ae3-c343-28ca-c083-b748d21a15e6	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077030 application number: ANDA077030 ndc (product): 60505-2522 ndc (product): 60505-2521
cilostazol	CILOSTAZOL	Aphena Pharma Solutions - Tennessee, LLC	15ead884-bd4f-7f4b-e063-6394a90a8f81	2024-04-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077030 application number: ANDA077030
cilostazol	CILOSTAZOL	Aphena Pharma Solutions - Tennessee, LLC	15478d90-312f-014e-e063-6294a90ae838	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077030 application number: ANDA077030

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-453	cilostazol	cilostazol	AvKARE	ANDA	Current
50268-176	cilostazol	cilostazol	AvPAK	ANDA	Current
50268-176	cilostazol	cilostazol	AvPAK	ANDA	Current
50268-177	cilostazol	cilostazol	AvPAK	ANDA	Current
50268-177	cilostazol	cilostazol	AvPAK	ANDA	Current
55154-6671	cilostazol	cilostazol	Cardinal Health	ANDA	Current
60505-2521	cilostazol	cilostazol	Apotex Corp.	ANDA	Current
60505-2522	cilostazol	cilostazol	Apotex Corp.	ANDA	Current
68788-9380	cilostazol	cilostazol	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2714	cilostazol	cilostazol	REMEDYREPACK INC.	ANDA	Current
70518-2714	cilostazol	cilostazol	REMEDYREPACK INC.	ANDA	Current
70518-2714	cilostazol	cilostazol	REMEDYREPACK INC.	ANDA	Current
70518-2714	cilostazol	cilostazol	REMEDYREPACK INC.	ANDA	Current