Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020980
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMISIL TERBINAFINE HYDROCHLORIDE 1% CREAM;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
03/09/1999 ORIG-1 Approval Type 8 - Partial Rx to OTC Switch STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20980_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20980.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/24/2014 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/10/2013 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/20/2012 SUPPL-9 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020980s009ltr.pdf
11/19/2009 SUPPL-7 Labeling

Label is not available on this site.

07/25/2007 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020980s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020980s005ltr.pdf
05/09/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/22/1999 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/25/2007 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020980s005lbl.pdf

LAMISIL

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

CREAM;TOPICAL; 1%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
LAMISIL TERBINAFINE HYDROCHLORIDE 1% CREAM;TOPICAL Over-the-counter Yes 020980 GLAXOSMITHKLINE
TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE 1% CREAM;TOPICAL Over-the-counter No 077511 TARO

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