Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078367
Company: REDDYS
Company: REDDYS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DESLORATADINE | DESLORATADINE | 2.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | None | No | No |
| DESLORATADINE | DESLORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING;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 |
|---|---|---|---|---|---|---|---|
| 07/12/2010 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078367s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/22/2019 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 02/11/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/18/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |