Application 021369

Type: NDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CODEPREX	CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX	SUSPENSION, EXTENDED RELEASE;ORAL	EQ 4MG MALEATE/5ML;EQ 20MG BASE/5ML	No	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
N021369-001	CODEPREX	CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX	EQ 4MG MALEATE/5ML;EQ 20MG BASE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL			2004-06-21

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	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021369-001	CODEPREX	EQ 4MG MALEATE/5ML;EQ 20MG BASE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2004-06-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021369-001	CODEPREX	EQ 4MG MALEATE/5ML;EQ 20MG BASE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2004-06-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021369-001	CODEPREX	EQ 4MG MALEATE/5ML;EQ 20MG BASE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2004-06-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021369-001	CODEPREX	EQ 4MG MALEATE/5ML;EQ 20MG BASE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	2004-06-21	`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
42125	ORIG	2005-04-05
5212	ORIG	2004-06-23