Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020519
Company: CNTY LINE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CICLOPIROX CICLOPIROX 0.77% GEL;TOPICAL Prescription AB 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
07/21/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/28/2013 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,020519s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018748Orig1s024,019824Orig1s023,020519Orig1s016ltr.pdf
03/26/2003 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20519slr005_loprox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20519slr005ltr.pdf
07/01/1999 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/10/1999 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/2000 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/25/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/28/2013 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,020519s016lbl.pdf
03/26/2003 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20519slr005_loprox_lbl.pdf

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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