Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021307
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOTRIMIN ULTRA BUTENAFINE 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
12/07/2001 ORIG-1 Approval Type 8 - Partial Rx to OTC Switch STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21307lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-307_Lotrimin_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-307_Lotrimin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/19/2017 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/18/2015 SUPPL-15 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021307Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021307Orig1s015ltr.pdf
12/17/2014 SUPPL-14 Efficacy-Manufacturing Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021307Orig1s014ltr.pdf
05/02/2012 SUPPL-13 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021307s013ltr.pdf
03/31/2011 SUPPL-12 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021307s012ltr.pdf
04/03/2006 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021307s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/18/2015 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021307Orig1s015lbl.pdf
12/07/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21307lbl.pdf

LOTRIMIN ULTRA

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
BUTENAFINE HYDROCHLORIDE BUTENAFINE HYDROCHLORIDE 1% CREAM;TOPICAL Over-the-counter No 205181 TARO PHARMS
LOTRIMIN ULTRA BUTENAFINE HYDROCHLORIDE 1% CREAM;TOPICAL Over-the-counter Yes 021307 BAYER HEALTHCARE LLC

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