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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019401
Company: UCB INC

Products on NDA 019401

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PSEUDO-12	PSEUDOEPHEDRINE POLISTIREX	EQ 60MG HYDROCHLORIDE/5ML	SUSPENSION, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019401

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/19/1987	ORIG-1	Approval	Type 2 - New Active Ingredient and Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

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