Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078366
Company: DR REDDYS LABS LTD
Company: DR REDDYS LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR | DESLORATADINE; PSEUDOEPHEDRINE SULFATE | 5MG;240MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/26/2011 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078366s000ltr.pdf |