Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018748
Company: MEDIMETRIKS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPROX CICLOPIROX 0.77% CREAM;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
12/30/1982 ORIG-1 Approval Type 1 - New Molecular Entity 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
01/13/2016 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

06/28/2013 SUPPL-24 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
08/17/2001 SUPPL-11 Manufacturing (CMC)-Formulation Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18748s11lbl.pdf
03/26/2003 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18748slr010_loprox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18748slr010ltr.pdf
09/15/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/23/1995 SUPPL-5 Labeling

Label is not available on this site.

04/26/1989 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/29/1986 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1985 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-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,020519s016lbl.pdf
03/26/2003 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18748slr010_loprox_lbl.pdf
08/17/2001 SUPPL-11 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18748s11lbl.pdf

LOPROX

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 COSETTE
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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