Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077412
Company: TEVA PHARMS
Company: TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | 5MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | 10MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | 20MG | TABLET; ORAL | None (Tentative Approval) | 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 |
---|---|---|---|---|---|---|---|
07/26/2006 | ORIG-1 | Tentative Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077412s000TAltr.pdf |