Application 204307

Type: NDA
Sponsor: PERSION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VITUZ	CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE	SOLUTION;ORAL	4MG/5ML;5MG/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
N204307-001	VITUZ	CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE	4MG/5ML;5MG/5ML	SOLUTION / ORAL		RLD	2013-02-20

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	N204307-001	VITUZ	4MG/5ML;5MG/5ML	SOLUTION / ORAL	RLD	2013-02-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204307-001	VITUZ	4MG/5ML;5MG/5ML	SOLUTION / ORAL	RLD	2013-02-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204307-001	VITUZ	4MG/5ML;5MG/5ML	SOLUTION / ORAL	RLD	2013-02-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204307-001	VITUZ	4MG/5ML;5MG/5ML	SOLUTION / ORAL	RLD	2013-02-20	`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	N204307-001	AA	1	`ea99ee380514…`

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
54837	SUPPL	2018-07-06
54804	SUPPL	2018-07-06
54765	SUPPL	2018-07-05
46913	SUPPL	2017-01-19
46868	SUPPL	2017-01-13
24465	ORIG	2013-09-20
22950	ORIG	2013-09-20
10318	ORIG	2013-02-25
19542	ORIG	2013-02-21