Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021022
Company: VALEANT BERMUDA
Company: VALEANT BERMUDA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PENLAC | CICLOPIROX | 8% | SOLUTION;TOPICAL | Prescription | AT | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 12/17/1999 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Patient Package Insert (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21022LBLB.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-022_Penlac.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/03/2004 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21022s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21022s004ltr.pdf | |
| 12/22/2003 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21022slr003_penlac_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21022slr003ltr.pdf | |
| 06/09/2003 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21022slr002_penlac_lacquer.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21022slr002ltr.pdf | |
| 02/09/2001 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/03/2004 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21022s004lbl.pdf | |
| 12/22/2003 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21022slr003_penlac_lbl.pdf | |
| 06/09/2003 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21022slr002_penlac_lacquer.pdf | |
| 12/17/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21022lbl.pdf |
PENLAC
SOLUTION;TOPICAL; 8%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CICLOPIROX | CICLOPIROX | 8% | SOLUTION;TOPICAL | Prescription | No | AT | 078172 | ACELLA |
| CICLOPIROX | CICLOPIROX | 8% | SOLUTION;TOPICAL | Prescription | No | AT | 078046 | ACTAVIS MID ATLANTIC |
| CICLOPIROX | CICLOPIROX | 8% | SOLUTION;TOPICAL | Prescription | No | AT | 078270 | AKORN |
| CICLOPIROX | CICLOPIROX | 8% | SOLUTION;TOPICAL | Prescription | No | AT | 078975 | AKORN |
| CICLOPIROX | CICLOPIROX | 8% | SOLUTION;TOPICAL | Prescription | No | AT | 078233 | COSETTE |
| CICLOPIROX | CICLOPIROX | 8% | SOLUTION;TOPICAL | Prescription | No | AT | 078124 | NOVAST LABS |
| CICLOPIROX | CICLOPIROX | 8% | SOLUTION;TOPICAL | Prescription | No | AT | 077623 | PERRIGO NEW YORK |
| CICLOPIROX | CICLOPIROX | 8% | SOLUTION;TOPICAL | Prescription | No | AT | 078144 | TARO PHARM INDS |
| PENLAC | CICLOPIROX | 8% | SOLUTION;TOPICAL | Prescription | Yes | AT | 021022 | VALEANT BERMUDA |
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