Application 070010

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	AMINOCAPROIC ACID	INJECTABLE;INJECTION	250MG/ML	No	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	AMINOCAPROIC ACID	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070010-001	AP

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 · 42 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
2026-08-18 06:07:40	2026-07	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070010-001	AMINOCAPROIC ACID IN PLASTIC CONTAINER	250MG/ML	INJECTABLE / INJECTION	AP	RS	1987-03-09	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A070010-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070010-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070010-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070010-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070010-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070010-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070010-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070010-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070010-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070010-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070010-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070010-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070010-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070010-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070010-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070010-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070010-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070010-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070010-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070010-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070010-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070010-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070010-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070010-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070010-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070010-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070010-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070010-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070010-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070010-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070010-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070010-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070010-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070010-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070010-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070010-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070010-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070010-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070010-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070010-001	AP	1	`e64feba35796…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aminocaproic Acid	AMINOCAPROIC ACID	Hospira, Inc.	1c5bc1dd-e9ec-44c1-9281-67ad482315d9	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070010 application number: ANDA070010 ndc (product): 0409-4346
Aminocaproic Acid	AMINOCAPROIC ACID	Medical Purchasing Solutions, LLC	4629d585-134b-a479-e063-6294a90a3432	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070010 application number: ANDA070010
AMINOCAPROIC ACID	AMINOCAPROIC ACID	Henry Schein, Inc.	5ff09f58-c225-4792-9f1e-9d2b7a413521	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070010 application number: ANDA070010 ndc (product): 0404-9812

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9812	AMINOCAPROIC ACID	AMINOCAPROIC ACID	Henry Schein, Inc.	ANDA	Current
0409-4346	Aminocaproic Acid	AMINOCAPROIC ACID	Hospira, Inc.	ANDA	Current
0409-4346	AMINOCAPROIC ACID	aminocaproic acid	Hospira, Inc.	ANDA	Current
0409-4346	Aminocaproic Acid	AMINOCAPROIC ACID	Hospira, Inc.	ANDA	Current
0409-4346	AMINOCAPROIC ACID	aminocaproic acid	Hospira, Inc.	ANDA	Current
0409-4346	Aminocaproic Acid	AMINOCAPROIC ACID	Hospira, Inc.	ANDA	Current
0409-4346	AMINOCAPROIC ACID	aminocaproic acid	Hospira, Inc.	ANDA	Current
52584-346	AMINOCAPROIC ACID	AMINOCAPROIC ACID	General Injectables and Vaccines, Inc.	ANDA	Current
52584-346	AMINOCAPROIC ACID	AMINOCAPROIC ACID	General Injectables and Vaccines, Inc.	ANDA	Current
52584-346	AMINOCAPROIC ACID	AMINOCAPROIC ACID	General Injectables and Vaccines, Inc.	ANDA	Current