Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075581
Company: TEVA
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KETOCONAZOLE | KETOCONAZOLE | 2% | CREAM;TOPICAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/25/2000 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-581_Ketoconazole_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75581ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-581_Ketoconazole.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/30/2001 | 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 |
---|---|---|---|---|---|
04/25/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-581_Ketoconazole_prntlbl.pdf |
KETOCONAZOLE
CREAM;TOPICAL; 2%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KETOCONAZOLE | KETOCONAZOLE | 2% | CREAM;TOPICAL | Prescription | No | AB | 212443 | ENCUBE |
KETOCONAZOLE | KETOCONAZOLE | 2% | CREAM;TOPICAL | Prescription | No | AB | 076294 | FOUGERA PHARMS |
KETOCONAZOLE | KETOCONAZOLE | 2% | CREAM;TOPICAL | Prescription | No | AB | 075581 | TEVA |
KETOCONAZOLE | KETOCONAZOLE | 2% | CREAM;TOPICAL | Prescription | No | AB | 215185 | TRUPHARMA |
KETOZOLE | KETOCONAZOLE | 2% | CREAM;TOPICAL | Prescription | No | AB | 075638 | TARO |