Application 213928

Type: ANDA
Sponsor: LEADING PHARMA LLC

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 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
A213928-001	AMINOCAPROIC ACID	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB		2021-02-12
A213928-002	AMINOCAPROIC ACID	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB		2021-02-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213928-001	AB
A213928-002	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 · 68 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	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213928-001	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	2021-02-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213928-002	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	2021-02-12	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 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	A213928-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213928-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213928-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213928-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213928-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213928-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213928-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213928-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213928-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213928-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213928-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213928-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213928-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213928-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213928-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213928-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213928-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213928-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213928-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213928-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213928-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213928-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213928-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213928-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213928-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213928-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213928-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213928-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213928-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213928-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213928-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213928-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213928-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213928-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213928-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213928-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213928-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213928-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213928-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213928-002	AB	1	`87673890dc5c…`

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	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	7d08ad63-71f5-4286-9622-84295668a293	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213928 application number: ANDA213928
AMINOCAPROIC ACID	AMINOCAPROIC ACID	Carnegie Pharmaceuticals, LLC	871ec401-30f8-4154-a16e-b82dc1e04b49	2023-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213928 application number: ANDA213928 ndc (product): 80005-129 ndc (product): 80005-128
AMINOCAPROIC ACID	AMINOCAPROIC ACID	Biocon Pharma Inc.	9205fb6b-24a0-1138-fd7b-cc33d0df5d6f	2021-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213928 application number: ANDA213928 ndc (product): 70377-103 ndc (product): 70377-102

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69315-231	AMINOCAPROIC ACID	AMINOCAPROIC ACID	Leading Pharma, LLC	ANDA	Current
69315-231	AMINOCAPROIC ACID	AMINOCAPROIC ACID	Leading Pharma, LLC	ANDA	Current
69315-232	AMINOCAPROIC ACID	AMINOCAPROIC ACID	Leading Pharma, LLC	ANDA	Current
69315-232	AMINOCAPROIC ACID	AMINOCAPROIC ACID	Leading Pharma, LLC	ANDA	Current
70377-102	AMINOCAPROIC ACID	AMINOCAPROIC ACID	Biocon Pharma Inc.	ANDA	Current
70377-103	AMINOCAPROIC ACID	AMINOCAPROIC ACID	Biocon Pharma Inc.	ANDA	Current
80005-128	AMINOCAPROIC ACID	AMINOCAPROIC ACID	Leading Pharma, LLC	ANDA	Current
80005-129	AMINOCAPROIC ACID	AMINOCAPROIC ACID	Leading Pharma, LLC	ANDA	Current