Application 213944

Type: ANDA
Sponsor: OPTIMUS

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	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A213944-001	AMINOCAPROIC ACID	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2022-09-14
A213944-002	AMINOCAPROIC ACID	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB		2022-09-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213944-001	AB
A213944-002	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 2 · 54 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
2026-08-18 06:07:40	2026-07	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213944-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2022-09-14	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213944-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2022-09-14	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213944-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213944-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213944-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213944-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213944-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213944-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213944-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213944-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213944-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213944-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213944-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213944-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213944-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213944-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213944-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213944-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213944-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213944-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213944-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213944-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213944-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213944-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213944-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213944-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213944-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213944-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213944-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213944-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213944-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213944-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213944-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213944-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213944-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213944-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213944-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213944-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213944-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213944-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213944-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213944-002	AB	1	`9b2671bbb829…`

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 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMINOCAPROIC ACID	AMINOCAPROIC ACID	Camber Pharmaceuticals, Inc.	89aa9680-d06c-4b5b-8908-c38a08e6466a	2022-11-09	Warnings, Adverse reactions	Name fallback brand name: AMINOCAPROIC ACID generic name: AMINOCAPROIC ACID
Aminocaproic Acid	AMINOCAPROIC ACID	Aurobindo Pharma Limited	48c6a773-7cde-4271-876a-4570a301f43a	2022-09-27	Warnings, Adverse reactions	Name fallback brand name: Aminocaproic Acid generic name: AMINOCAPROIC ACID
AMINOCAPROIC ACID	AMINOCAPROIC ACID	Biocon Pharma Inc.	9205fb6b-24a0-1138-fd7b-cc33d0df5d6f	2021-08-12	Warnings, Adverse reactions	Name fallback brand name: AMINOCAPROIC ACID generic name: AMINOCAPROIC ACID
Aminocaproic Acid	AMINOCAPROIC ACID	Vitruvias Therapeutics	555a0910-dbeb-4643-8b3a-c9fe9b803b3c	2021-03-15	Warnings, Adverse reactions	Name fallback brand name: Aminocaproic Acid generic name: AMINOCAPROIC ACID
AMINOCAPROIC ACID	AMINOCAPROIC ACID	Biocon Pharma Inc.	c3cadb3a-4f63-06ee-0dd2-6828dbc1fffa	2021-01-27	Warnings, Adverse reactions	Name fallback brand name: AMINOCAPROIC ACID generic name: AMINOCAPROIC ACID
Aminocaproic Acid	AMINOCAPROIC ACID	Civica, Inc.	36283eb3-f98e-446f-ade7-ce7864cd5779	2020-09-21	Warnings, Adverse reactions	Name fallback brand name: Aminocaproic Acid generic name: AMINOCAPROIC ACID
Aminocaproic Acid	AMINOCAPROIC ACID	American Regent, Inc.	08bfb83e-3ac5-4e66-84a3-fcd4deaf73ae	2020-07-16	Warnings, Adverse reactions	Name fallback brand name: Aminocaproic Acid generic name: AMINOCAPROIC ACID
Aminocaproic Acid	AMINOCAPROIC ACID	American Regent, Inc.	f4f65667-c349-420b-b7b7-f20f3a4e4d4e	2019-12-06	Warnings, Adverse reactions	Name fallback brand name: Aminocaproic Acid generic name: AMINOCAPROIC ACID

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13925-530	Aminocaproic Acid	Aminocaproic Acid	Seton Pharmaceuticals, LLC	ANDA	Current
13925-531	Aminocaproic Acid	Aminocaproic Acid	Seton Pharmaceuticals, LLC	ANDA	Current