Application 208085

Type: NDA
Sponsor: ECI PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XTRELUS	GUAIFENESIN; HYDROCODONE BITARTRATE	TABLET;ORAL	400MG;5MG	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
N208085-001	XTRELUS	GUAIFENESIN; HYDROCODONE BITARTRATE	400MG;5MG	TABLET / ORAL		RLD	2018-04-25

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	N208085-001	XTRELUS	400MG;5MG	TABLET / ORAL	RLD	2018-04-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208085-001	XTRELUS	400MG;5MG	TABLET / ORAL	RLD	2018-04-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208085-001	XTRELUS	400MG;5MG	TABLET / ORAL	RLD	2018-04-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208085-001	XTRELUS	400MG;5MG	TABLET / ORAL	RLD	2018-04-25	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84681	SUPPL	2026-01-06
84538	SUPPL	2025-12-23
77018	SUPPL	2023-12-19
76923	SUPPL	2023-12-18
76922	SUPPL	2023-12-18
56742	ORIG	2018-12-14
56299	SUPPL	2018-11-06
56241	SUPPL	2018-11-01
53865	ORIG	2018-04-27
53822	ORIG	2018-04-26