Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021763
Company: BIOVAIL LABS INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None No No
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None No No
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None No No
CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE 40MG TABLET; ORALLY DISINTEGRATING Prescription 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
12/20/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021763lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021763ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021763s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/20/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021763lbl.pdf

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