Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021440
Company: FOREST LABS
Company: FOREST LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEXAPRO | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET; ORAL | Prescription | None | No | No |
LEXAPRO | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET; ORAL | Prescription | None | No | No |
LEXAPRO | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET; ORAL | 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 |
---|---|---|---|---|---|---|---|
08/29/2002 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-440.pdf_Lexapro_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21323se8-001and21440ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-440_21323s1_Lexapro.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/29/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-440.pdf_Lexapro_Prntlbl.pdf |