Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078112
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIDANOSINE | DIDANOSINE | 10MG/ML | FOR SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 03/08/2007 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078112ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/31/2012 | SUPPL-4 | Labeling-Package Insert, REMS-Modified |
Label is not available on this site. |
||
| 12/27/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/29/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |