Application 209060

Type: ANDA
Sponsor: SUNNY PHARMTECH INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMINOCAPROIC ACID	AMINOCAPROIC ACID	TABLET;ORAL	500MG	No	No
002	AMINOCAPROIC ACID	AMINOCAPROIC ACID	TABLET;ORAL	1GM	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
A209060-001	AMINOCAPROIC ACID	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27
A209060-002	AMINOCAPROIC ACID	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209060-001	AB
A209060-002	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	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209060-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2018-11-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209060-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RS	2018-11-27	`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	A209060-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209060-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209060-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209060-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209060-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209060-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209060-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209060-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209060-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209060-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209060-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209060-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209060-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209060-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209060-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209060-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209060-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209060-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209060-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209060-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209060-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209060-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209060-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209060-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209060-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209060-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209060-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209060-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209060-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209060-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209060-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209060-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209060-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209060-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209060-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209060-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209060-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209060-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209060-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209060-002	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aminocaproic Acid	AMINOCAPROIC ACID	American Health Packaging	4c2612ab-86a4-4c54-a5c0-e837f755965f	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209060 application number: ANDA209060
Aminocaproic Acid	AMINOCAPROIC ACID	Vitruvias Therapeutics	555a0910-dbeb-4643-8b3a-c9fe9b803b3c	2021-03-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209060 application number: ANDA209060 ndc (product): 69680-115 ndc (product): 69680-116

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60687-505	Aminocaproic Acid	Aminocaproic Acid	American Health Packaging	ANDA	Current
60687-505	Aminocaproic Acid	Aminocaproic Acid	American Health Packaging	ANDA	Current
60687-505	Aminocaproic Acid	Aminocaproic Acid	American Health Packaging	ANDA	Current
69680-115	Aminocaproic Acid	Aminocaproic Acid	Vitruvias Therapeutics	ANDA	Current
69680-115	Aminocaproic Acid	Aminocaproic Acid	Vitruvias Therapeutics	ANDA	Current
69680-115	Aminocaproic Acid	Aminocaproic Acid	Vitruvias Therapeutics	ANDA	Current
69680-116	Aminocaproic Acid	Aminocaproic Acid	Vitruvias Therapeutics	ANDA	Current
69680-116	Aminocaproic Acid	Aminocaproic Acid	Vitruvias Therapeutics	ANDA	Current
69680-116	Aminocaproic Acid	Aminocaproic Acid	Vitruvias Therapeutics	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56867	ORIG	2018-12-20