Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021369
Company: LANNETT CO INC

Products on NDA 021369

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CODEPREX	CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX	EQ 4MG MALEATE/5ML;EQ 20MG BASE/5ML	SUSPENSION, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021369

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21369ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-369_Codeprex.cfm