Application 204977

Type: NDA
Sponsor: OSMOTICA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMTRYG	OMEGA-3-ACID ETHYL ESTERS TYPE A	CAPSULE;ORAL	1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	Yes	No

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

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
N204977-001	OMTRYG	OMEGA-3-ACID ETHYL ESTERS TYPE A	1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL		RLD	2014-04-23

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N204977-001	OMTRYG	1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	RLD	2014-04-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204977-001	OMTRYG	1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	RLD	2014-04-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204977-001	OMTRYG	1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	RLD	2014-04-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204977-001	OMTRYG	1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	RLD	2014-04-23	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204977-001	NCE	2019-04-23	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N204977-001	NCE	2019-04-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204977-001	NCE	2019-04-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204977-001	NCE	2019-04-23	`ea99ee380514…`

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61112-001	Omtryg	omega-3-acid ethyl esters	Trygg Pharma Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82638	SUPPL	2025-06-24
82629	SUPPL	2025-06-23
40430	SUPPL	2016-03-22
22971	ORIG	2014-12-18
40429	ORIG	2014-04-25
32607	ORIG	2014-04-25