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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018748
Company: MEDIMETRIKS PHARMS

Products on NDA 018748

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOPROX	CICLOPIROX	0.77%	CREAM;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018748

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.

Labels for NDA 018748

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

Therapeutic Equivalents for NDA 018748

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	PADAGIS 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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