Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021763
Company: BIOVAIL LABS INTL
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 | Yes | No |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 20MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | No |
| CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | EQ 40MG BASE | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | 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 |