Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074971
Company: CHARTWELL RX
Company: CHARTWELL RX
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/99/74-971_Ketoconazole_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74971ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-971_Ketoconazole.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/16/2023 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
08/01/2023 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
02/18/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
11/15/2017 | SUPPL-2 | Labeling-Package Insert |
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/99/74-971_Ketoconazole_prntlbl.pdf |