Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019356
Company: SEBELA IRELAND LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAFTIN NAFTIFINE HYDROCHLORIDE 1% GEL;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
06/18/1990 ORIG-1 Approval Type 3 - New Dosage Form 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-8 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
09/26/2007 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019356s007ltr.pdf
07/01/2002 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/30/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/24/1997 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1990 SUPPL-1 Manufacturing (CMC)

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-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019356s008,019599s014,204286s003lbl.pdf

NAFTIN

GEL;TOPICAL; 1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAFTIFINE HYDROCHLORIDE NAFTIFINE HYDROCHLORIDE 1% GEL;TOPICAL Prescription No AB 206165 TOLMAR
NAFTIN NAFTIFINE HYDROCHLORIDE 1% GEL;TOPICAL Prescription Yes AB 019356 SEBELA IRELAND LTD

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