Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075597
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KETOCONAZOLE | KETOCONAZOLE | 200MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/23/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75597ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/16/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/15/2017 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/25/2017 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/25/2017 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/05/2014 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/2007 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |