Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020539
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMISIL TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL 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
05/10/1996 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20539S10ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/29/2019 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020539s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020539Orig1s033ltr.pdf
01/19/2017 SUPPL-29 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020539s029,022071s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020539Orig1s029,022071Orig1s013ltr.pdf
11/15/2016 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

11/03/2016 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/23/2016 SUPPL-26 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020539s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020539Orig1s026ltr.pdf
02/12/2016 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/23/2013 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020539s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020539Orig1s024ltr.pdf
06/17/2013 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020539s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020539Orig1s023ltr.pdf
04/23/2012 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020539s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020539s021ltr.pdf
11/04/2011 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020539s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020539s020ltr.pdf
03/30/2011 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020539s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020539s018ltr.pdf
12/02/2010 SUPPL-17 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020539s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020539s017ltr.pdf
11/10/2005 SUPPL-13 Labeling

Label is not available on this site.

01/21/2004 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20539slr012_lamisil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20539slr012ltr.pdf
12/27/2001 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/13/2001 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20539S10ltr.pdf
04/30/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/21/1999 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/05/1999 SUPPL-3 Efficacy-Labeling Change With Clinical Data

Label is not available on this site.

10/04/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/06/1996 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
03/29/2019 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020539s033lbl.pdf
01/19/2017 SUPPL-29 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020539s029,022071s013lbl.pdf
08/23/2016 SUPPL-26 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020539s026lbl.pdf
08/23/2016 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020539s026lbl.pdf
10/23/2013 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020539s024lbl.pdf
06/17/2013 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020539s023lbl.pdf
04/23/2012 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020539s021lbl.pdf
11/04/2011 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020539s020lbl.pdf
03/30/2011 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020539s018lbl.pdf
12/02/2010 SUPPL-17 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020539s017lbl.pdf
01/21/2004 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20539slr012_lamisil_lbl.pdf

LAMISIL

TABLET;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LAMISIL TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription Yes AB 020539 NOVARTIS
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 078297 AUROBINDO PHARMA
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 077714 BRECKENRIDGE PHARM
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 077137 CIPLA
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 076390 DR REDDYS LABS INC
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 078157 GLENMARK GENERICS
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 077919 HARRIS PHARM
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 076377 HERITAGE PHARMA
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 077533 INVAGEN PHARMS
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Prescription No AB 078163 ORCHID HLTHCARE

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English