Application 022439

Type: NDA
Sponsor: PERSION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZUTRIPRO	CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE	SOLUTION;ORAL	4MG/5ML;5MG/5ML;60MG/5ML	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
N022439-001	ZUTRIPRO	CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2011-06-08

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	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2011-06-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2011-06-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2011-06-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022439-001	ZUTRIPRO	4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2011-06-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	N022439-001	AA	1	`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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60258-876	Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine HCl	hydrocodone bitartrate, chlorpheniramine maleate, pseudoephedrine hydrochloride	Cypress Pharmaceutical, Inc.	NDA	Current
63717-876	ZUTRIPRO	hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride	Hawthorn Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54839	SUPPL	2018-07-06
54783	SUPPL	2018-07-06
54760	SUPPL	2018-07-05
46909	SUPPL	2017-01-19
46866	SUPPL	2017-01-13
42529	ORIG	2012-02-03
44754	ORIG	2012-01-23
29733	ORIG	2011-06-13
38716	ORIG	2011-06-10