Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019824
Company: MEDIMETRIKS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPROX CICLOPIROX 0.77% SUSPENSION;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
12/30/1988 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
10/04/2016 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

06/28/2013 SUPPL-23 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-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19824slr009_loprox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19824slr009ltr.pdf
03/26/2003 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19824slr008_loprox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19824slr008ltr.pdf
06/09/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/17/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/23/1995 SUPPL-3 Labeling

Label is not available on this site.

09/11/1990 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/1989 SUPPL-1 Labeling

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-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,020519s016lbl.pdf
03/26/2003 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19824slr009_loprox_lbl.pdf
03/26/2003 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19824slr008_loprox_lbl.pdf

LOPROX

SUSPENSION;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% SUSPENSION;TOPICAL Prescription No AB 076422 FOUGERA PHARMS
CICLOPIROX CICLOPIROX 0.77% SUSPENSION;TOPICAL Prescription No AB 077676 PERRIGO NEW YORK
CICLOPIROX CICLOPIROX 0.77% SUSPENSION;TOPICAL Prescription No AB 077092 TARO
LOPROX CICLOPIROX 0.77% SUSPENSION;TOPICAL Prescription Yes AB 019824 MEDIMETRIKS PHARMS

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