Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021124
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMISIL AT TERBINAFINE HYDROCHLORIDE 1% SOLUTION;TOPICAL Over-the-counter None Yes Yes
LAMISIL AT TERBINAFINE HYDROCHLORIDE 1% SPRAY;TOPICAL Over-the-counter None 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
03/17/2000 ORIG-1 Approval Type 8 - Partial Rx to OTC Switch STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21124lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21124ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-124_TerbinafineLamisil.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/13/2013 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021124Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021124Orig1s013ltr.pdf
03/20/2012 SUPPL-11 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021124s011ltr.pdf
02/12/2010 SUPPL-9 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021124s009ltr.pdf
06/15/2009 SUPPL-8 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021124s008ltr.pdf
07/25/2008 SUPPL-7 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021124s007ltr.pdf
07/25/2002 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/08/2002 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/11/2002 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/09/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/13/2013 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021124Orig1s013lbl.pdf
03/17/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21124lbl.pdf

LAMISIL AT

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SOLUTION;TOPICAL; 1%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
LAMISIL AT TERBINAFINE HYDROCHLORIDE 1% SOLUTION;TOPICAL Over-the-counter Yes 021124 NOVARTIS

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPRAY;TOPICAL; 1%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
LAMISIL AT TERBINAFINE HYDROCHLORIDE 1% SPRAY;TOPICAL Over-the-counter Yes 021124 NOVARTIS

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