Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018713
Company: BAYER HLTHCARE
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MYCELEX CLOTRIMAZOLE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TROCHE/LOZENGE;ORAL Discontinued None Yes No
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.

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

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