Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077364
Company: PERRIGO ISRAEL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CICLOPIROX CICLOPIROX 0.77% CREAM;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
03/03/2006 ORIG-1 Approval

Label is not available on this site.

CICLOPIROX

CREAM;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% CREAM;TOPICAL Prescription No AB 078463 ACP NIMBLE
CICLOPIROX CICLOPIROX 0.77% CREAM;TOPICAL Prescription No AB 076435 FOUGERA PHARMS
CICLOPIROX CICLOPIROX 0.77% CREAM;TOPICAL Prescription No AB 090273 GLENMARK PHARMS
CICLOPIROX CICLOPIROX 0.77% CREAM;TOPICAL Prescription No AB 077364 PERRIGO ISRAEL
CICLOPIROX CICLOPIROX 0.77% CREAM;TOPICAL Prescription No AB 076790 TARO
LOPROX CICLOPIROX 0.77% CREAM;TOPICAL Prescription Yes AB 018748 MEDIMETRIKS PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English