Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077550
Company: DASH PHARMS
Company: DASH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 05/14/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/077550s000TAltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/10/2023 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |