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Drugs@FDA: FDA-Approved Drugs

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

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