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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021307
Company: BAYER HEALTHCARE LLC

Products on NDA 021307

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021307

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
04/19/2024	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021307Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021307Orig1s023ltr.pdf
01/02/2024	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021307Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021307Orig1s022ltr.pdf
08/29/2023	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021307Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021307Orig1s021ltr.pdf
10/18/2021	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021307Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021307Orig1s019ltr.pdf
12/15/2020	SUPPL-18	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021307Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021307Orig1s018ltr.pdf
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

Labels for NDA 021307

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2024	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021307Orig1s023lbl.pdf
01/02/2024	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021307Orig1s022lbl.pdf
08/29/2023	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021307Orig1s021lbl.pdf
10/18/2021	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021307Orig1s019lbl.pdf
12/15/2020	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021307Orig1s018lbl.pdf
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

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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
LOTRIMIN ULTRA	BUTENAFINE HYDROCHLORIDE	1%	CREAM;TOPICAL	Over-the-counter	Yes	021307	BAYER HEALTHCARE LLC

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