Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076422
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CICLOPIROX | CICLOPIROX | 0.77% | SUSPENSION;TOPICAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
08/06/2004 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76422ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076422_CiclopiroxTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/11/2006 | SUPPL-4 | Labeling |
Label is not available on this site. |
CICLOPIROX
SUSPENSION;TOPICAL; 0.77%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CICLOPIROX | CICLOPIROX | 0.77% | SUSPENSION;TOPICAL | Prescription | No | AB | 076422 | FOUGERA PHARMS |
CICLOPIROX | CICLOPIROX | 0.77% | SUSPENSION;TOPICAL | Prescription | No | AB | 077676 | PADAGIS ISRAEL |
CICLOPIROX | CICLOPIROX | 0.77% | SUSPENSION;TOPICAL | Prescription | No | AB | 077092 | TARO |
LOPROX | CICLOPIROX | 0.77% | SUSPENSION;TOPICAL | Prescription | Yes | AB | 019824 | MEDIMETRIKS PHARMS |