Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020192
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMISIL TERBINAFINE HYDROCHLORIDE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CREAM;TOPICAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/30/1992 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
09/03/1998 SUPPL-14 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020192_S014_LAMISIL_CREAM.pdf
06/30/1997 SUPPL-13 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020192_S013_LAMISIL_CREAM.pdf
04/03/1997 SUPPL-12 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020192_S012_LAMISIL.pdf
01/21/1997 SUPPL-11 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020192_S011_LAMISIL.pdf
10/04/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/06/1996 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1996 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/1995 SUPPL-6 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020192_S006_LAMISIL_CREAM.pdf
10/17/1995 SUPPL-5 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020192_S005_LAMISIL_CREAM.pdf
04/25/1995 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1997 SUPPL-3 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020192_S003.pdf
08/04/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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