Application 015197

Type: NDA
Sponsor: CLOVER PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMICAR	AMINOCAPROIC ACID	TABLET;ORAL	500MG	Yes	No
002	AMICAR	AMINOCAPROIC ACID	TABLET;ORAL	1GM	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N015197-001	AMICAR	AMINOCAPROIC ACID	500MG	TABLET / ORAL	AB	RLD, Approved before 1982
N015197-002	AMICAR	AMINOCAPROIC ACID	1GM	TABLET / ORAL	AB	RLD	2004-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N015197-001	AB
N015197-002	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 3 of 3 · 88 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
2022-10-28 04:53 UTC	2022-10	N015197-001	AMICAR	500MG	TABLET / ORAL	AB	RLD, Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N015197-002	AMICAR	1GM	TABLET / ORAL	AB	RLD	2004-06-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N015197-001	AMICAR	500MG	TABLET / ORAL	AB	RLD, Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N015197-002	AMICAR	1GM	TABLET / ORAL	AB	RLD	2004-06-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N015197-001	AMICAR	500MG	TABLET / ORAL	AB	RLD, Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N015197-002	AMICAR	1GM	TABLET / ORAL	AB	RLD	2004-06-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N015197-001	AMICAR	500MG	TABLET / ORAL	AB	RLD, Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N015197-002	AMICAR	1GM	TABLET / ORAL	AB	RLD	2004-06-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N015197-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N015197-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N015197-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N015197-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N015197-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N015197-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N015197-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N015197-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N015197-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N015197-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N015197-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N015197-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N015197-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N015197-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N015197-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N015197-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N015197-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N015197-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N015197-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N015197-002	AB	1	`2680178bc6a6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N015197-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N015197-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N015197-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N015197-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N015197-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N015197-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N015197-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N015197-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N015197-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N015197-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N015197-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N015197-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N015197-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N015197-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N015197-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N015197-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N015197-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N015197-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N015197-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N015197-002	AB	1	`c0c555d07b60…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aminocaproic Acid	AMINOCAPROIC ACID	Hikma Pharmaceuticals USA Inc.	7b8f0ddb-00fd-4c22-afae-afe636f95f3a	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 015197 application number: NDA015197

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-768	Aminocaproic Acid	Aminocaproic Acid	Akorn Operating Company LLC	NDA AUTHORIZED GENERIC	Current
17478-768	Aminocaproic Acid	Aminocaproic Acid	Akorn Inc.	NDA AUTHORIZED GENERIC	Current
17478-768	Aminocaproic Acid	Aminocaproic Acid	Akorn Inc.	NDA AUTHORIZED GENERIC	Current
17478-769	Aminocaproic Acid	Aminocaproic Acid	Akorn Operating Company LLC	NDA AUTHORIZED GENERIC	Current
17478-769	Aminocaproic Acid	Aminocaproic Acid	Akorn Inc.	NDA AUTHORIZED GENERIC	Current
17478-769	Aminocaproic Acid	Aminocaproic Acid	Akorn Inc.	NDA AUTHORIZED GENERIC	Current
49411-050	AMICAR	Aminocaproic Acid	Akorn Operating Company LLC	NDA	Current
49411-050	AMICAR	Aminocaproic Acid	Clover Pharmaceuticals Corp.	NDA	Current
49411-050	AMICAR	Aminocaproic Acid	Clover Pharmaceuticals Corp.	NDA	Current
49411-050	AMICAR	Aminocaproic Acid	Akorn Operating Company LLC	NDA	Current
49411-051	AMICAR	Aminocaproic Acid	Akorn Operating Company LLC	NDA	Current
49411-051	AMICAR	Aminocaproic Acid	Clover Pharmaceuticals Corp.	NDA	Current
49411-051	AMICAR	Aminocaproic Acid	Clover Pharmaceuticals Corp.	NDA	Current
49411-051	AMICAR	Aminocaproic Acid	Akorn Operating Company LLC	NDA	Current
61748-046	Aminocaproic Acid	Aminocaproic Acid	VersaPharm Inc - an Akorn Company	NDA AUTHORIZED GENERIC	Current
61748-046	Aminocaproic Acid	Aminocaproic Acid	Versapharm Incorporated	NDA AUTHORIZED GENERIC	Current
68151-3023	AMICAR	Aminocaproic Acid	Carilion Materials Management	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10856	SUPPL	2008-08-26
12079	SUPPL	2008-08-22
12078	SUPPL	2004-08-25
33133	SUPPL	2004-06-25
33132	SUPPL	2004-06-25
33131	SUPPL	2004-06-25
12077	SUPPL	2004-06-25
10855	SUPPL	2004-06-25
397	SUPPL	2004-06-25
396	SUPPL	2004-06-25
395	SUPPL	2004-06-25