An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018713
Company: BAYER HLTHCARE

Products on NDA 018713

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYCELEX	CLOTRIMAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TROCHE/LOZENGE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018713

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/1983	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
12/15/2002	SUPPL-19	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18713slr019_mycelex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18713slr019ltr.pdf
03/26/2001	SUPPL-17	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018713_S017_MYCELEX TROCHE_AP.pdf
01/23/2001	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
10/07/1999	SUPPL-14	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/018713_S014_MYCELEX TROCHE_AP.pdf
06/30/1999	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
12/30/1991	SUPPL-11	Labeling		Label is not available on this site.
01/18/1990	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
09/15/1989	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/07/1988	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
09/29/1992	SUPPL-7	Efficacy-New Indication		Label is not available on this site.
01/15/1988	SUPPL-6	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
01/27/1988	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
06/03/1987	SUPPL-4	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018713_S004_MYCELEX TROCHE_AP.pdf
09/11/1985	SUPPL-2	Labeling		Label is not available on this site.
11/13/1984	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 018713

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2002	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18713slr019_mycelex_lbl.pdf

Top