Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077896
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CICLOPIROX | CICLOPIROX | 0.77% | GEL;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 |
---|---|---|---|---|---|---|---|
06/10/2008 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/27/2011 | SUPPL-2 | Labeling |
Label is not available on this site. |
CICLOPIROX
GEL;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% | GEL;TOPICAL | Prescription | No | AB | 077896 | FOUGERA PHARMS |
CICLOPIROX | CICLOPIROX | 0.77% | GEL;TOPICAL | Prescription | No | AB | 091595 | GLENMARK PHARMS INC |
CICLOPIROX | CICLOPIROX | 0.77% | GEL;TOPICAL | Prescription | No | AB | 078266 | PADAGIS US |