Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076419
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KETOCONAZOLE | KETOCONAZOLE | 2% | SHAMPOO;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 |
---|---|---|---|---|---|---|---|
01/07/2004 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076419.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/31/2015 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
03/18/2013 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
02/04/2011 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
02/01/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
KETOCONAZOLE
SHAMPOO;TOPICAL; 2%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KETOCONAZOLE | KETOCONAZOLE | 2% | SHAMPOO;TOPICAL | Prescription | No | AB | 076942 | COSETTE |
KETOCONAZOLE | KETOCONAZOLE | 2% | SHAMPOO;TOPICAL | Prescription | No | AB | 218498 | NOVITIUM PHARMA |
KETOCONAZOLE | KETOCONAZOLE | 2% | SHAMPOO;TOPICAL | Prescription | No | AB | 076419 | PADAGIS ISRAEL |