Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090490
Company: ACTAVIS MID ATLANTIC
Company: ACTAVIS MID ATLANTIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CICLOPIROX | CICLOPIROX | 1% | SHAMPOO;TOPICAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
11/24/2009 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090490s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/18/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
04/30/2013 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
CICLOPIROX
SHAMPOO;TOPICAL; 1%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CICLOPIROX | CICLOPIROX | 1% | SHAMPOO;TOPICAL | Prescription | No | AT | 090490 | ACTAVIS MID ATLANTIC |
CICLOPIROX | CICLOPIROX | 1% | SHAMPOO;TOPICAL | Prescription | No | AT | 090146 | FOUGERA PHARMS |
CICLOPIROX | CICLOPIROX | 1% | SHAMPOO;TOPICAL | Prescription | No | AT | 078594 | PADAGIS US |
CICLOPIROX | CICLOPIROX | 1% | SHAMPOO;TOPICAL | Prescription | No | AT | 090269 | TARO |
LOPROX | CICLOPIROX | 1% | SHAMPOO;TOPICAL | Prescription | Yes | AT | 021159 | BAUSCH |