Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090094
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIDANOSINE | DIDANOSINE | 125MG | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | No | No |
| DIDANOSINE | DIDANOSINE | 200MG | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | No | No |
| DIDANOSINE | DIDANOSINE | 250MG | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | No | No |
| DIDANOSINE | DIDANOSINE | 400MG | CAPSULE, DELAYED REL PELLETS;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 |
|---|---|---|---|---|---|---|---|
| 09/24/2008 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090094_PEPFAR_APLetter.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/14/2019 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/14/2019 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/31/2012 | SUPPL-9 | REMS-Modified, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/27/2011 | SUPPL-8 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/22/2010 | SUPPL-6 | Labeling-Package Insert, REMS-Proposal |
Label is not available on this site. |
||
| 09/02/2009 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/14/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |