Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075273
Company: TEVA
Company: TEVA
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 |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-273_Ketoconazole_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75273ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-273_Ketoconazole.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/16/2023 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
02/28/2020 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
11/15/2017 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
10/25/2017 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
10/25/2017 | SUPPL-14 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
08/30/2001 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
09/05/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/07/2000 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/15/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-273_Ketoconazole_prntlbl.pdf |