Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076435
Company: FOUGERA PHARMS
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
12/29/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/076435ltr.pdf

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

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