Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075362
Company: HERITAGE PHARMA
Company: HERITAGE PHARMA
| 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 |
|---|---|---|---|---|---|---|---|
| 06/15/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75362ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/16/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/28/2020 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/03/2017 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/15/2017 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/20/2001 | SUPPL-2 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |