Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019599
Company: SEBELA IRELAND LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAFTIN NAFTIFINE HYDROCHLORIDE 1% CREAM;TOPICAL Discontinued None Yes No
NAFTIN NAFTIFINE HYDROCHLORIDE 2% CREAM;TOPICAL 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
02/29/1988 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
04/30/2018 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019356s008,019599s014,204286s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019356Orig1s008,019599Orig1s014,204286Orig1s003ltr.pdf
11/10/2016 SUPPL-13 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019599s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019599Orig1s013ltr.pdf
10/10/2014 SUPPL-12 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019599s012lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019599Orig1s012ltr.pdf
01/13/2012 SUPPL-11 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019599s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019599s011ltr.pdf
01/26/2009 SUPPL-10 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019599s010ltr.pdf
08/10/2006 SUPPL-9 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/04/2002 SUPPL-7 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019599Orig1s007.pdf
11/30/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/24/1997 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1995 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/30/1990 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/1990 SUPPL-2 Efficacy-New Dosing Regimen

Label is not available on this site.

04/05/1989 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/30/2018 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019356s008,019599s014,204286s003lbl.pdf
11/10/2016 SUPPL-13 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019599s013lbl.pdf
10/10/2014 SUPPL-12 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019599s012lbledt.pdf
01/13/2012 SUPPL-11 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019599s011lbl.pdf

NAFTIN

CREAM;TOPICAL; 2%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAFTIFINE HYDROCHLORIDE NAFTIFINE HYDROCHLORIDE 2% CREAM;TOPICAL Prescription No AB 206901 TARO PHARMS
NAFTIFINE HYDROCHLORIDE NAFTIFINE HYDROCHLORIDE 2% CREAM;TOPICAL Prescription No AB 206960 TOLMAR
NAFTIN NAFTIFINE HYDROCHLORIDE 2% CREAM;TOPICAL Prescription Yes AB 019599 SEBELA IRELAND LTD

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