Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091595
Company: GLENMARK GENERICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CICLOPIROX CICLOPIROX 0.77% GEL;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
02/29/2012 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/01/2014 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

CICLOPIROX

GEL;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% GEL;TOPICAL Prescription Yes AB 020519 CNTY LINE PHARMS
CICLOPIROX CICLOPIROX 0.77% GEL;TOPICAL Prescription No AB 077896 FOUGERA PHARMS
CICLOPIROX CICLOPIROX 0.77% GEL;TOPICAL Prescription No AB 091595 GLENMARK GENERICS
CICLOPIROX CICLOPIROX 0.77% GEL;TOPICAL Prescription No AB 078266 PADDOCK LLC

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