Details for New Drug Application (NDA): 021022
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The generic ingredient in PENLAC is ciclopirox. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.
Summary for 021022
Tradename: | PENLAC |
Applicant: | Valeant Bermuda |
Ingredient: | ciclopirox |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;TOPICAL | Strength | 8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 17, 1999 | TE: | RLD: | Yes |
Expired US Patents for NDA 021022
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Valeant Bermuda | PENLAC | ciclopirox | SOLUTION;TOPICAL | 021022-001 | Dec 17, 1999 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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