Application 209525

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ICOSAPENT ETHYL	ICOSAPENT ETHYL	CAPSULE;ORAL	500MG	No	No
002	ICOSAPENT ETHYL	ICOSAPENT ETHYL	CAPSULE;ORAL	1G	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
A209525-001	ICOSAPENT ETHYL	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB		2020-09-11
A209525-002	ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB		2020-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209525-001	AB
A209525-002	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.

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
2026-08-01 22:54:32	2026-06	A209525-001	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB		2020-09-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209525-002	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB		2020-09-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A209525-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209525-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
Icosapent Ethyl	ICOSAPENT ETHYL	Teva Pharmaceuticals, Inc.	de7049ae-d1d6-4267-a93b-dd5039c50c2c	2021-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209525 application number: ANDA209525 ndc (product): 0480-0127 ndc (product): 0480-0126

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0480-0126	Icosapent Ethyl	Icosapent Ethyl	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-0126	Icosapent Ethyl	Icosapent Ethyl	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-0127	Icosapent Ethyl	Icosapent Ethyl	Teva Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65089	ORIG	2020-10-30
64401	ORIG	2020-08-24