Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018050
Company: UCB INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORSYM CHLORPHENIRAMINE POLISTIREX; PHENYLPROPANOLAMINE POLISTIREX EQ 4MG MALEATE/5ML;EQ 37.5MG HCL/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
01/04/1984 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/15/1988 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/19/1987 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/28/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1985 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1985 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/1984 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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